Orthopedic

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