| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| HRR | Scissors, Orthopedic, Surgical | 第 1 类 | 21 CFR 888.4540 | 8 |
| HRS | Plate, Fixation, Bone | 第 2 类 | 21 CFR 888.3030 | 1323 |
| HRT | Stripper, Surgical | 第 1 类 | 21 CFR 888.4540 | |
| HRW | Dynamometer, Nonpowered | 第 1 类 | 21 CFR 888.1250 | 12 |
| HRX | Arthroscope | 第 2 类 | 21 CFR 888.1100 | 683 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Poly | 第 2 类 | 21 CFR 888.3530 | 91 |
| HRZ | Prosthesis, Knee, Hinged (Metal-Metal) | 第 3 类 | 21 CFR 888.3480 | |
| HSA | Prosthesis, Knee, Hemi-, Femoral | 第 3 类 | 21 CFR 888.3570 | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 第 2 类 | 21 CFR 888.3020 | 530 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 第 2 类 | 21 CFR 888.3690 | 71 |
| HSH | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) | 第 2 类 | 21 CFR 888.3590 | 5 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 第 2 类 | 21 CFR 888.3110 | 68 |
| HSP | Splint, Traction | 第 1 类 | 21 CFR 888.5890 | 1 |
| HSQ | Belt, Pelvic, Traction | 第 1 类 | 21 CFR 888.5890 | 1 |
| HSR | Unit, Traction, Hip, Non-Powered, Non-Penetrating | 第 1 类 | 21 CFR 888.5890 | 1 |
| HSS | Halter, Head, Traction | 第 1 类 | 21 CFR 888.5890 | 3 |
| HST | Apparatus, Traction, Non-Powered | 第 1 类 | 21 CFR 888.5850 | 38 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polym | 第 2 类 | 21 CFR 888.3520 | 115 |
| HTG | Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented | 第 2 类 | 21 CFR 888.3580 | 2 |
| HTH | Protractor | 第 1 类 | 21 CFR 888.4600 | 3 |
| HTJ | Gauge, Depth | 第 1 类 | 21 CFR 888.4300 | 4 |
| HTN | Washer, Bolt Nut | 第 2 类 | 21 CFR 888.3030 | 93 |
| HTO | Reamer | 第 1 类 | 21 CFR 888.4540 | 14 |
| HTP | File | 第 1 类 | 21 CFR 888.4540 | 5 |
| HTQ | Broach | 第 1 类 | 21 CFR 888.4540 | |
| HTS | Knife, Orthopedic | 第 1 类 | 21 CFR 888.4540 | 9 |
| HTT | Burr, Orthopedic | 第 1 类 | 21 CFR 888.4540 | 4 |
| HTW | Bit, Drill | 第 1 类 | 21 CFR 888.4540 | 11 |
| HTX | Rongeur | 第 1 类 | 21 CFR 888.4540 | 5 |
| HTY | Pin, Fixation, Smooth | 第 2 类 | 21 CFR 888.3040 | 205 |
| HWA | Impactor | 第 1 类 | 21 CFR 888.4540 | 4 |
| HWB | Extractor | 第 1 类 | 21 CFR 888.4540 | 5 |
| HWC | Screw, Fixation, Bone | 第 2 类 | 21 CFR 888.3040 | 1064 |
| HWD | Starter, Bone Screw | 第 1 类 | 21 CFR 888.4540 | |
| HWI | Corkscrew | 第 1 类 | 21 CFR 888.4540 | 1 |
| HWJ | Awl | 第 1 类 | 21 CFR 888.4540 | 4 |
| HWK | Trephine | 第 1 类 | 21 CFR 888.4540 | 1 |
| HWL | Set, Hollow Mill | 第 1 类 | 21 CFR 888.4540 | |
| HWN | Instrument, Compression | 第 1 类 | 21 CFR 888.4540 | 4 |
| HWO | Skid, Bone | 第 1 类 | 21 CFR 888.4540 | |
| HWP | Punch, Femoral Neck | 第 1 类 | 21 CFR 888.4540 | 1 |
| HWQ | Passer | 第 1 类 | 21 CFR 888.4540 | 9 |
| HWR | Driver, Prosthesis | 第 1 类 | 21 CFR 888.4540 | 4 |
| HWT | Template | 第 1 类 | 21 CFR 888.4800 | 10 |
| HWW | Countersink | 第 1 类 | 21 CFR 888.4540 | |
| HWX | Tap, Bone | 第 1 类 | 21 CFR 888.4540 | 2 |
| HXA | Prosthesis, Tendon, Passive | 第 2 类 | 21 CFR 888.3025 | 11 |
| HXB | Probe | 第 1 类 | 21 CFR 888.4540 | 15 |
| HXC | Wrench | 第 1 类 | 21 CFR 888.4540 | 6 |
| HXE | Fork | 第 1 类 | 21 CFR 888.4540 | |
| HXG | Tamp | 第 1 类 | 21 CFR 888.4540 | 1 |
| HXI | Passer, Wire, Orthopedic | 第 1 类 | 21 CFR 888.4540 | 3 |
| HXJ | Staple Driver | 第 1 类 | 21 CFR 888.4540 | 6 |
| HXK | Holder, Needle; Orthopedic | 第 1 类 | 21 CFR 888.4540 | 5 |
| HXN | Applier, Cerclage | 第 1 类 | 21 CFR 888.4540 | 2 |
| HXO | Pusher, Socket | 第 1 类 | 21 CFR 888.4540 | 3 |
| HXP | Instrument, Bending Or Contouring | 第 1 类 | 21 CFR 888.4540 | 5 |
| HXQ | Crimper, Pin | 第 1 类 | 21 CFR 888.4540 | |
| HXS | Twister, Wire | 第 1 类 | 21 CFR 888.4540 | 2 |
| HXW | Bender | 第 1 类 | 21 CFR 888.4540 | 3 |
| HXX | Screwdriver | 第 1 类 | 21 CFR 888.4540 | 4 |
| HXY | Brace, Drill | 第 1 类 | 21 CFR 888.4540 | 7 |
| HXZ | Cutter, Wire | 第 1 类 | 21 CFR 888.4540 | 1 |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 第 2 类 | 21 CFR 888.3160 | 27 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 第 2 类 | 21 CFR 888.3150 | 29 |
| JDD | Prosthesis, Upper Femoral | 第 2 类 | 21 CFR 888.3360 | |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 第 2 类 | 21 CFR 888.3360 | 59 |
| JDH | Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal | 第 3 类 | 21 CFR 888.3380 | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 第 2 类 | 21 CFR 888.3350 | 565 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component | 第 3 类 | 21 CFR 888.3320 | 45 |
| JDN | Implant, Fixation Device, Spinal | 第 2 类 | 21 CFR 888.3060 | 6 |
| JDO | Device, Fixation, Proximal Femoral, Implant | 第 2 类 | 21 CFR 888.3030 | 23 |
| JDP | Condylar Plate Fixation Implant | 第 2 类 | 21 CFR 888.3030 | 2 |
| JDQ | Cerclage, Fixation | 第 2 类 | 21 CFR 888.3010 | 130 |
| JDR | Staple, Fixation, Bone | 第 2 类 | 21 CFR 888.3030 | 232 |
| JDS | Nail, Fixation, Bone | 第 2 类 | 21 CFR 888.3030 | 53 |
| JDT | Cap, Bone | 第 1 类 | 21 CFR 888.3000 | |
| JDW | Pin, Fixation, Threaded | 第 2 类 | 21 CFR 888.3040 | 94 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 第 2 类 | 21 CFR 888.4580 | 23 |
| JDY | Evacuator, Vapor, Cement Monomer | 第 1 类 | 21 CFR 888.4220 | 8 |
| JDZ | Mixer, Cement, For Clinical Use | 第 1 类 | 21 CFR 888.4210 | 13 |
| JEC | Component, Traction, Invasive | 第 2 类 | 21 CFR 888.3040 | 85 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Pol | 第 2 类 | 21 CFR 888.3560 | 915 |
| JWI | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | 第 2 类 | 21 CFR 888.3800 | 3 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Const | 第 2 类 | 21 CFR 888.3800 | 17 |
| KIG | Prosthesis, Wrist, Constrained, Polymer | 第 2 类 | 21 CFR 888.3780 | |
| KIH | Dispenser, Cement | 第 1 类 | 21 CFR 888.4200 | 11 |
| KII | Tube, Cement Ventilation | 第 1 类 | 21 CFR 888.4230 | |
| KIL | Positioner, Socket | 第 1 类 | 21 CFR 888.4540 | 1 |
| KMB | Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylen | 第 2 类 | 21 CFR 888.3490 | |
| KMC | Prosthesis, Hip, Semi-Constrained, Composite/Metal | 第 2 类 | 21 CFR 888.3340 | 3 |
| KMD | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite | 第 2 类 | 21 CFR 888.3100 | |
| KQW | Goniometer, Nonpowered | 第 1 类 | 21 CFR 888.1520 | 13 |
| KQX | Goniometer, Ac-Powered | 第 1 类 | 21 CFR 888.1500 | 33 |
| KQZ | Component, Traction, Non-Invasive | 第 1 类 | 21 CFR 888.5890 | 11 |
| KRN | Metal Cemented Constrained Femorotibial Knee Prosthesis | 第 3 类 | 21 CFR 888.3480 | |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 第 2 类 | 21 CFR 888.3510 | 87 |
| KRP | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer | 第 3 类 | 21 CFR 888.3550 | |
| KRQ | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer | 第 2 类 | 21 CFR 888.3550 | |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/P | 第 2 类 | 21 CFR 888.3540 | 27 |
| KRS | Prosthesis, Knee, Hemi-, Femoral (Uncemented) | 第 3 类 | 21 CFR 888.3570 | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 第 2 类 | 21 CFR 888.3030 | 404 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 第 2 类 | 21 CFR 888.3030 | 38 |
| KTX | Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemen | 第 2 类 | 21 CFR 888.3490 | |
| KTZ | Caliper | 第 1 类 | 21 CFR 888.4150 | 7 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Compone | 第 3 类 | 21 CFR 888.3330 | 114 |
| KWB | Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal | 第 3 类 | 21 CFR 888.3370 | |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 第 2 类 | 21 CFR 888.3730 | 46 |
| KWE | Prosthesis, Finger, Constrained, Metal, Uncemented | 第 3 类 | 21 CFR 888.3200 | |
| KWF | Prosthesis, Finger, Polymer | 第 2 类 | 21 CFR 888.3230 | |
| KWG | Prosthesis, Finger, Constrained, Metal/Polymer | 第 3 类 | 21 CFR 888.3220 | |
| KWH | Prosthesis, Toe, Constrained, Polymer | 第 2 类 | 21 CFR 888.3720 | 21 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 第 2 类 | 21 CFR 888.3170 | 34 |
| KWJ | Prosthesis, Elbow, Hemi-, Humeral, Metal | 第 3 类 | 21 CFR 888.3180 | |
| KWK | Appliance, Nail/Blade/Plate Combination, Single Component | 第 2 类 | 21 CFR 888.3030 | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 第 2 类 | 21 CFR 888.3360 | 108 |
| KWM | Prosthesis, Wrist, Semi-Constrained | 第 2 类 | 21 CFR 888.3800 | 6 |
| KWN | Prosthesis, Wrist, Carpal Lunate | 第 2 类 | 21 CFR 888.3750 | 5 |
| KWO | Prosthesis, Wrist, Carpal Scaphoid | 第 2 类 | 21 CFR 888.3760 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 第 2 类 | 21 CFR 888.3050 | 430 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 第 2 类 | 21 CFR 888.3060 | 667 |
| KWR | Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cement | 第 3 类 | 21 CFR 888.3640 | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 第 2 类 | 21 CFR 888.3660 | 191 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 第 2 类 | 21 CFR 888.3650 | 71 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 第 2 类 | 21 CFR 888.3390 | 99 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 第 2 类 | 21 CFR 888.3310 | 34 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 第 2 类 | 21 CFR 888.3400 | 23 |
| KXB | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer | 第 3 类 | 21 CFR 888.3410 | |
| KXC | Prosthesis, Ankle, Cemented, Non-Constrained | 第 3 类 | 21 CFR 888.3120 | |
| KXD | Prosthesis, Hip, Constrained, Metal | 第 3 类 | 21 CFR 888.3300 | |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 第 2 类 | 21 CFR 888.3810 | 16 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 第 2 类 | 21 CFR 888.3770 | 26 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 第 2 类 | 21 CFR 888.3230 | 14 |
| KYK | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Comp | 第 2 类 | 21 CFR 888.3500 | 3 |
| KYM | Metallic Cemented Glenoid Hemi-Shoulder Prosthesis | 第 3 类 | 21 CFR 888.3680 | |
| KYN | Prosthesis, Wrist, Constrained, Metal | 第 3 类 | 21 CFR 888.3790 | |
| LBB | Dynamometer, Ac-Powered | 第 2 类 | 21 CFR 888.1240 | 36 |
| LBC | Prosthesis, Finger, Constrained, Metal, Cemented | 第 3 类 | 21 CFR 888.3210 | |
| LGE | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-B | 第 2 类 | 21 CFR 888.3530 | 2 |
| LGF | Component, Cast | 第 1 类 | 21 CFR 888.5940 | 31 |
| LGG | Instrument, Cast Application/Removal, Manual | 第 1 类 | 21 CFR 888.5980 | 3 |
| LGH | Instrument, Cast Removal, Ac-Powered | 第 1 类 | 21 CFR 888.5960 | 9 |
| LOD | Bone Cement | 第 2 类 | 21 CFR 888.3027 | 72 |
| LOF | Stimulator, Bone Growth, Non-Invasive | 第 2 类 | 21 CFR 890.5870 | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 第 2 类 | 21 CFR 888.3358 | 564 |
| LPQ | Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therape | 第 2 类 | 21 CFR 890.5870 | |
| LRN | Wire, Surgical | 第 2 类 | 21 CFR 888.3030 | 8 |
| LTO | Spacer, Cement | 第 3 类 | 21 CFR 888.3320 | |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 第 2 类 | 21 CFR 888.3360 | 81 |
| LXH | Orthopedic Manual Surgical Instrument | 第 1 类 | 21 CFR 888.4540 | 58 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, | 第 2 类 | 21 CFR 888.3030 | 57 |
| LYP | Accessories, Fixation, Spinal Interlaminal | 第 2 类 | 21 CFR 888.3050 | 1 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | 第 1 类 | 21 CFR 888.4540 | 3 |
| LYS | Bone Mill | 第 1 类 | 21 CFR 888.4540 | 4 |
| LYT | Fixation Accessory | 第 2 类 | 21 CFR 888.3030 | 9 |
| LZE | Isometer | 第 1 类 | 21 CFR 888.1520 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or | 第 2 类 | 21 CFR 888.3353 | 532 |
| LZV | System, Cement Removal Extraction | 第 2 类 | 21 CFR 888.4580 | 7 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | 第 2 类 | 21 CFR 888.3360 | 8 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 第 2 类 | 21 CFR 888.3030 | 221 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 第 2 类 | 21 CFR 888.3080 | 896 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or | 第 2 类 | 21 CFR 888.3353 | 4 |
| MBB | Bone Cement, Antibiotic | 第 2 类 | 21 CFR 888.3027 | 19 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 第 2 类 | 21 CFR 888.3670 | 37 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, | 第 2 类 | 21 CFR 888.3565 | 144 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 第 2 类 | 21 CFR 888.3040 | 601 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | 第 2 类 | 21 CFR 888.3358 | 13 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 第 2 类 | 21 CFR 888.3045 | 31 |
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegg | 第 2 类 | 21 CFR 888.3560 | 14 |
| MDI | Prosthesis, Rib Replacement | 第 2 类 | 21 CFR 888.3070 | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Po | 第 2 类 | 21 CFR 888.3353 | 160 |
| MJW | Prosthesis, Subtalar, Plug, Polymer | 第 2 类 | 21 CFR 888.3040 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 第 2 类 | 21 CFR 888.3070 | 309 |
| MNI | Orthosis, Spinal Pedicle Fixation | 第 2 类 | 21 CFR 888.3070 | 303 |
| MNU | Staple, Absorbable | 第 2 类 | 21 CFR 888.3030 | 4 |
| MQP | Spinal Vertebral Body Replacement Device | 第 2 类 | 21 CFR 888.3060 | 279 |
| MQV | Filler, Bone Void, Calcium Compound | 第 2 类 | 21 CFR 888.3045 | 492 |
| MRY | Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple | 第 2 类 | 21 CFR 888.3040 | |
| NBH | Accessories, Arthroscopic | 第 1 类 | 21 CFR 888.1100 | 2 |
| NDD | Cerclage, Fixation, Metallic | 第 2 类 | 21 CFR 888.3010 | 1 |
| NDE | Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collap | 第 2 类 | 21 CFR 888.3020 | |
| NDF | Plate, Fixation, Bone, Non-Spinal, Metallic | 第 2 类 | 21 CFR 888.3030 | 3 |
| NDG | Washer, Bolt, Nut, Non-Spinal, Metallic | 第 2 类 | 21 CFR 888.3030 | 1 |
| NDH | Nail, Fixation, Bone, Metallic | 第 2 类 | 21 CFR 888.3030 | |
| NDI | Staple, Fixation, Bone, Metallic | 第 2 类 | 21 CFR 888.3030 | |
| NDJ | Screw, Fixation, Bone, Non-Spinal, Metallic | 第 2 类 | 21 CFR 888.3040 | |
| NDK | System, External Fixator (With Metallic Invasive Components) | 第 2 类 | 21 CFR 888.3040 | 3 |
| NDL | Pin, Fixation, Smooth, Metallic | 第 2 类 | 21 CFR 888.3040 | 2 |
| NDM | Pin, Fixation, Threaded, Metallic | 第 2 类 | 21 CFR 888.3040 | 1 |
| NDN | Cement, Bone, Vertebroplasty | 第 2 类 | 21 CFR 888.3027 | 108 |
| NGR | Tester, Stiffness, Cartilage, Arthroscopic | 第 2 类 | 21 CFR 888.1100 | 2 |
| NJA | Accessory, System, External Fixator, Containing Antimicrobial Agent | 第 2 类 | 21 CFR 888.3040 | |
| NJD | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncement | 第 2 类 | 21 CFR 888.3535 | 5 |
| NKB | Thoracolumbosacral Pedicle Screw System | 第 2 类 | 21 CFR 888.3070 | 905 |
| NKG | Posterior Cervical Screw System | 第 2 类 | 21 CFR 888.3075 | 118 |
| NKI | Goniometer With Electrodes | 第 2 类 | 21 CFR 888.1500 | 1 |
| NOV | Anchor, Suture, Bone Fixation, Metallic | 第 2 类 | 21 CFR 888.3030 | 1 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemen | 第 2 类 | 21 CFR 888.3560 | 12 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 第 2 类 | 21 CFR 888.3070 | 22 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 第 2 类 | 21 CFR 888.3050 | 30 |