FDA Device Registration & Listing · AUDUBON, PA, US · Registration 3004142400
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2014-02-12 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2023-05-16 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | Class 1 | 862.2050 | 2023-05-16 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2008-12-22 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2014-07-29 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-07-29 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2014-07-29 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2014-07-29 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2014-07-29 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-07-30 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2023-06-13 |
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | Class 1 | 888.4210 | 2023-06-13 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2022-02-03 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2022-02-03 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-02-03 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2023-06-13 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3350 | 2023-06-13 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2023-06-13 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2023-06-13 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Orthopedic | Class 2 | 888.3353 | 2023-06-13 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2023-06-13 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2023-06-13 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2023-06-13 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2012-11-14 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2008-12-15 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-01-20 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2012-01-20 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2024-08-23 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2013-04-29 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-12-23 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-01-20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-10-07 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-10-07 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2003-08-19 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2025-07-10 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2024-08-23 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2008-12-15 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2004-11-03 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2023-06-13 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | Class 2 | 864.9245 | 2023-05-16 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2017-07-24 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2008-12-15 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2013-04-29 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2023-06-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-08-29 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2024-04-01 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2012-01-20 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2012-01-20 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2019-03-01 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2019-03-01 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-04-09 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2019-04-09 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2019-04-09 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2019-04-09 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2012-01-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2012-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2012-12-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2012-12-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-12-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-12-04 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-12-04 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2012-12-04 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-12-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-12-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2012-12-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-12-04 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2015-05-28 |
| NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown | Class 3 | N/A | 2014-02-12 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2008-12-15 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2015-01-28 |
| OWI | Bone Fixation Cerclage, Sublaminar | Orthopedic | Class 2 | 888.3010 | 2023-04-21 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2008-02-26 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2008-02-26 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2008-02-26 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2015-01-28 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-12-30 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2023-06-13 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2004-11-03 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2004-11-03 |
| JDS | Nail, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-04-27 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-04-27 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2026-04-27 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2020-11-10 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-11-10 |
| MJO | Prosthesis, Intervertebral Disc | Unknown | Class 3 | N/A | 2012-11-26 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2015-09-22 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2015-09-22 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2015-09-22 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-04-07 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Orthopedic | Class 2 | 888.3030 | 2018-03-16 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2018-03-16 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-11-26 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2018-09-13 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2024-01-29 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2024-01-29 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2012-11-26 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2012-11-26 |
| HWR | Driver, Prosthesis | Orthopedic | Class 1 | 888.4540 | 2024-08-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-04-25 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-04-25 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2016-04-25 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2016-04-25 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2016-04-25 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2015-05-28 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2018-06-26 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2022-11-18 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2022-11-18 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2022-11-18 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2023-06-30 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-02-20 |
| PEK | Spinous Process Plate | Orthopedic | Class 2 | 888.3050 | 2015-01-28 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2018-11-07 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2018-11-07 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2024-12-18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2015-09-22 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2015-09-22 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2017-01-26 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2014-02-12 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-11-26 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2009-12-18 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-09-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-09-23 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | Orthopedic | Class 2 | 888.3360 | 2023-06-13 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2008-12-15 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-01-28 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-08-03 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-08-03 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | Class 2 | 864.9245 | 2023-05-16 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2023-06-13 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-05-16 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2015-01-28 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-11-14 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-11-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-11-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-11-14 |
| CAC | Apparatus, Autotransfusion | Anesthesiology | Class 2 | 868.5830 | 2023-05-16 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2012-11-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-11-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2012-11-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-11-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-11-14 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2012-11-14 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-04-14 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Orthopedic | Class 2 | 888.3060 | 2018-11-14 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2018-11-14 |
| MJO | Prosthesis, Intervertebral Disc | Unknown | Class 3 | N/A | 2014-02-12 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2022-08-22 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2022-08-22 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2016-09-28 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2016-09-28 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2016-09-28 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2020-08-07 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2020-08-07 |
| PGM | Growing Rod System | Orthopedic | Class 2 | 888.3070 | 2026-05-11 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-05-11 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-05-11 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2026-05-11 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2018-08-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2018-08-07 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2012-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2009-12-18 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2021-01-27 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2021-01-27 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2021-01-27 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-01-20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2008-02-26 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2003-08-19 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2003-08-19 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2007-01-03 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2007-01-03 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2007-01-03 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2007-01-03 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2007-01-03 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-01-20 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2014-02-12 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2023-06-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2009-12-18 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2017-07-24 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2017-07-24 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2008-02-26 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2017-07-24 |
| ITQ | Joint, Knee, External Brace | Physical Medicine | Class 1 | 890.3475 | 2024-11-12 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | Hematology | Class 2 | 864.9245 | 2023-05-16 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2024-08-23 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2023-11-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-01-20 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2009-12-18 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2009-12-18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2009-12-18 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2009-12-18 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2014-02-12 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2008-02-26 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2024-08-23 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2025-06-18 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-06-18 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-06-18 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-06-18 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2008-12-15 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2008-12-15 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Orthopedic | Class 2 | 888.3170 | 2008-12-15 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2008-12-15 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2008-12-15 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2023-06-13 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2023-06-13 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4820 | 2024-04-01 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2009-12-18 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2009-12-18 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2009-12-18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2009-12-18 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2009-12-18 |
| OWI | Bone Fixation Cerclage, Sublaminar | Orthopedic | Class 2 | 888.3010 | 2019-02-06 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2023-06-13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2019-04-08 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2013-08-26 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2008-12-29 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2022-11-28 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2022-11-28 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-11-28 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2022-11-28 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-11-28 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-11-28 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2020-01-14 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Orthopedic | Class 2 | 888.3353 | 2022-12-19 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2022-12-19 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2022-12-19 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3350 | 2022-12-19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2022-12-19 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2022-12-19 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2022-12-19 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2022-12-19 |
| PEK | Spinous Process Plate | Orthopedic | Class 2 | 888.3050 | 2018-06-26 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Orthopedic | Class 2 | 888.3070 | 2014-02-12 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2024-08-23 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2023-05-16 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | Class 1 | 862.2050 | 2023-05-16 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2008-12-22 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2008-12-22 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2008-12-22 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2008-12-22 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2008-12-22 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2024-08-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2013-08-26 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-09-25 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2019-09-25 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-09-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2008-12-15 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | Class 2 | 864.9245 | 2023-05-16 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-10-06 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2021-10-06 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2024-04-01 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-08-09 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-08-09 |
| JDQ | Cerclage, Fixation | Orthopedic | Class 2 | 888.3010 | 2023-08-09 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2012-01-20 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2023-05-16 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-08-26 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-08-26 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-08-26 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-08-26 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2013-08-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-08-26 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-30 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-30 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2026-04-30 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-30 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2026-04-30 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2004-11-03 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2012-11-29 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2021-05-24 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2021-05-24 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2023-06-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2014-02-12 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-05-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2018-05-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-05-10 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2015-01-28 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-01-13 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2020-01-13 |
| HTQ | Broach | Orthopedic | Class 1 | 888.4540 | 2024-08-23 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2024-07-11 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2024-07-11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2024-07-11 |
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | General, Plastic Surgery | Class 2 | 878.5040 | 2023-05-16 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2023-06-13 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2008-12-15 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2008-02-26 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2008-02-26 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2008-02-26 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2008-02-26 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | Class 1 | 862.2050 | 2023-05-16 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2009-12-18 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-11-26 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-13 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2016-03-16 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-09-22 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-09-22 |
| PGM | Growing Rod System | Orthopedic | Class 2 | 888.3070 | 2023-01-05 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2008-12-15 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2024-04-23 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2024-04-23 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-04-23 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-03-24 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-01-20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-10-25 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | General, Plastic Surgery | Class 1 | 878.4950 | 2025-04-30 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-01-28 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Orthopedic | Class 2 | 888.3070 | 2009-12-18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2014-02-12 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2024-08-23 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2023-06-13 |
| QHP | Vertebral Body Tethering System | Unknown | Class N | N/A | 2023-05-16 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-04-29 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-06-26 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3000779542 | Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allografts | San Antonio, TX, US |
| 3011713200 | GLOBUS MEDICAL, INC. | Methuen, MA, US |
| 3030412764 | GLOBUS MEDICAL, INC. | Memphis, TN, US |
| 3013491327 | NML Medical, LLC | West Carrollton, OH, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K032604 | Co-Ligne AG | GII SPINAL FIXATION SYSTEM | 2004-01-20 |
| K964304 | Osteonics Corp. | OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY | 1997-01-17 |
| K880350 | Honway International Co. | YUE/FA DISPOSABLE SYRINGE | 1988-02-16 |
| K003571 | Terumo Medical Corp. | SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE | 2001-02-12 |
| K180121 | Cellumed Co., Ltd. | Rafugen DBM | 2018-04-11 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes |
| Z-0004-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes |
| Z-0005-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes |
| Z-0005-2024 | Fresenius Medical Care Holdings, Inc. | 2 | 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case |
| Z-0006-2024 | Fresenius Medical Care Holdings, Inc. | 2 | 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3009941480 | LISI MEDICAL REmmele | Big Lake, MN, US |
| 3004635447 | C&W SWISS, INC. | CLAYTON, OH, US |
| 3015869493 | Jabil Switzerland Manufacturing GmbH (Mezzovico) | Mezzovico Ticino, CH |
| 3016050940 | Olive Branch Distribution Center | Olive Branch, MS, US |
| 3009417901 | SYNTHES GMBH | Zuchwil Solothurn, CH |
3004142400 when referencing this establishment in official correspondence.