| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| NUD | Vertebroplasty Compound, Calcium Based | 第 2 类 | 21 CFR 888.3027 | |
| NVC | Bone, Heterograft | 第 3 类 | 21 CFR 888.3015 | |
| NWN | Laparoscopic Bone Anchor Urethropexy Instrument Kit | 第 2 类 | 21 CFR 888.3040 | |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | 第 1 类 | 21 CFR 888.4200 | 1 |
| OBL | Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty | 第 2 类 | 21 CFR 888.3027 | 1 |
| OBM | Cement, Bone, Vertebroplasty, Pre-Formed, Modular | 第 2 类 | 21 CFR 888.3027 | |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | 第 2 类 | 21 CFR 888.3030 | 6 |
| OCG | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented | 第 3 类 | 21 CFR 888.3410 | |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | 第 1 类 | 21 CFR 888.4540 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 第 2 类 | 21 CFR 888.3080 | 354 |
| OIS | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | 第 2 类 | 21 CFR 888.3045 | 1 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Pol | 第 2 类 | 21 CFR 888.3560 | 12 |
| OJB | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate | 第 2 类 | 21 CFR 888.3060 | 3 |
| OJM | Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh | 第 2 类 | 21 CFR 888.3060 | |
| OOG | Knee Arthroplasty Implantation System | 第 2 类 | 21 CFR 888.3560 | 2 |
| OOL | Electronic Depth Gauge | 第 2 类 | 21 CFR 888.3030 | 1 |
| OQB | Intervertebral Body Graft Containment Device | 第 2 类 | 21 CFR 888.3085 | 4 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, | 第 2 类 | 21 CFR 888.3358 | 20 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | 第 2 类 | 21 CFR 888.3350 | |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Por | 第 2 类 | 21 CFR 888.3353 | 5 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 第 2 类 | 21 CFR 888.3070 | 19 |
| OSN | Software For Diagnosis/Treatment | 第 2 类 | 21 CFR 888.3030 | 4 |
| OUR | Sacroiliac Joint Fixation | 第 2 类 | 21 CFR 888.3040 | 132 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 第 2 类 | 21 CFR 888.3080 | 204 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 第 2 类 | 21 CFR 888.3080 | 166 |
| OVZ | Pin, Fixation, Resorbable, Hard Tissue | 第 2 类 | 21 CFR 888.3040 | 3 |
| OWI | Bone Fixation Cerclage, Sublaminar | 第 2 类 | 21 CFR 888.3010 | 37 |
| OYK | Ankle Arthroplasty Implantation System | 第 2 类 | 21 CFR 888.3110 | 7 |
| OZI | Internal Hinged Elbow Fixator | 第 2 类 | 21 CFR 888.3030 | 3 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Ceme | 第 2 类 | 21 CFR 888.3660 | 1 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 第 2 类 | 21 CFR 888.3030 | 27 |
| PBI | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + | 第 2 类 | 21 CFR 888.3310 | 2 |
| PEK | Spinous Process Plate | 第 2 类 | 21 CFR 888.3050 | 48 |
| PGM | Growing Rod System | 第 2 类 | 21 CFR 888.3070 | 14 |
| PGN | Growing Rod System- Magnetic Actuation | 第 2 类 | 21 CFR 888.3070 | 9 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | 第 2 类 | 21 CFR 888.3080 | 3 |
| PHQ | Anterior Staple As Supplemental Fixation For Fusion | 第 2 类 | 21 CFR 888.3060 | 2 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 第 2 类 | 21 CFR 888.3660 | 205 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral St | 第 2 类 | 21 CFR 888.3660 | 19 |
| PLF | Bone Wedge | 第 2 类 | 21 CFR 888.3030 | 18 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 第 2 类 | 21 CFR 888.3060 | 19 |
| PLW | Acetabular Cup Orientation System | 第 2 类 | 21 CFR 888.3350 | 1 |
| PML | Bone Cement, Posterior Screw Augmentation | 第 2 类 | 21 CFR 888.3027 | 19 |
| PPQ | Transtibial Anterior Cruciate Ligament Kit | 第 2 类 | 21 CFR 888.3040 | |
| PPR | Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures | 第 2 类 | 21 CFR 888.1100 | |
| PQC | Pedicle Screw Placement Guide | 第 2 类 | 21 CFR 888.3070 | 8 |
| QAC | Screw Sleeve Bone Fixation Device | 第 2 类 | 21 CFR 888.3043 | 1 |
| QAD | Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Ac | 第 2 类 | 21 CFR 888.3023 | 7 |
| QBO | Instruments Designed For Press-Fit Osteochondral Implants | 第 2 类 | 21 CFR 888.4505 | 2 |
| QFP | Intraoperative Orthopedic Strain Sensor | 第 2 类 | 21 CFR 888.3090 | 1 |
| QGQ | Bone Indentation Device | 第 2 类 | 21 CFR 888.1600 | 3 |
| QHE | Shoulder Arthroplasty Implantation System | 第 2 类 | 21 CFR 888.3660 | 26 |
| QHG | Defect Measurement Tool | 第 2 类 | 21 CFR 888.4510 | 1 |
| QHQ | Total Shoulder Arthroplasty System | 第 2 类 | 21 CFR 888.3660 | 1 |
| QJD | Absorbable Metallic Bone Fixation Fastener | 第 2 类 | 21 CFR 888.3041 | 1 |
| QKW | Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Ceme | 第 2 类 | 21 CFR 888.3695 | 1 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Device | 第 2 类 | 21 CFR 888.4515 | 9 |
| QLR | Manual Instruments Designed For Use With Non-Fusion Spinous Process Sp | 第 2 类 | 21 CFR 888.4520 | 1 |
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | 第 2 类 | 21 CFR 888.3044 | 3 |
| QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 第 2 类 | 21 CFR 888.3600 | 4 |
| QPQ | Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, | 第 2 类 | 21 CFR 888.3630 | 1 |
| QRR | Filler, Bone Void, Calcium Compound Containing Single Approved Aminogl | 第 2 类 | 21 CFR 888.3046 | 2 |
| QSD | Posterior Cervical Screw Placement Guide | 第 2 类 | 21 CFR 888.3075 | 2 |
| QSR | Sacroiliac Screw Placement Guide | 第 2 类 | 21 CFR 888.3040 | 1 |
| QVI | Screw Sleeve Bone Fixation Device, Spine | 第 2 类 | 21 CFR 888.3043 | 2 |
| QVL | Absorbable Gel For Intraoperative Use In Spine Surgery | 第 2 类 | 21 CFR 888.3047 | 2 |
| QVV | Medial Knee Implanted Shock Absorber | 第 2 类 | 21 CFR 888.3610 | 1 |
| QWL | Intraoperative Surgical Angle Measurement Tool | 第 2 类 | 21 CFR 888.4560 | 3 |
| QZO | Wearable Vibration Device For Orthopedic Use | 第 2 类 | 21 CFR 888.5895 | 1 |
| QZY | Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide | 第 2 类 | 21 CFR 888.3071 | 1 |
| QZZ | Limb And Joint Salvage Device With Coating For Bacteria Reduction | 第 2 类 | 21 CFR 888.3900 | 3 |
| SAI | Ankle Fusion Cage | 第 2 类 | 21 CFR 888.3020 | 2 |
| SCY | Sacroiliac Joint Guidewire Placement Device | 第 2 类 | 21 CFR 888.3040 | 1 |
| SGL | Manual Instruments Designed For Use With Non-Fusion Spinous Process Te | 第 2 类 | 21 CFR 888.4520 | 1 |
| SIN | Automated Intraoperative Spinal Rod Bending System | 第 2 类 | 21 CFR 888.3070 | 1 |
| SIQ | Intra-Articular Orthopedic Stereotaxic Navigation Instrument | 第 2 类 | 21 CFR 888.4561 | 1 |
| SIT | Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality | 第 2 类 | 21 CFR 888.1150 | 1 |
| SJA | Injectable For Thermal Treatment Of Musculoskeletal Pain | 第 2 类 | 21 CFR 888.3048 | 1 |