FDA Device Registration & Listing · Little Ferry, NJ, US · Registration 3009959868
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2019-12-31 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2012-11-15 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | Class 2 | 874.1820 | 2026-02-04 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | Class 2 | 890.1375 | 2026-02-04 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2026-02-04 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | Class 2 | 882.1870 | 2026-02-04 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | Class 2 | 882.1870 | 2026-02-04 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | Class 2 | 874.1820 | 2026-02-04 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2026-02-04 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | Class 2 | 890.1375 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-01-20 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2022-01-20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-20 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-07-23 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-02-04 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-02-04 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-02-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-12-31 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-12-31 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-07-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2018-12-21 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-02-04 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| OWI | Bone Fixation Cerclage, Sublaminar | Orthopedic | Class 2 | 888.3010 | 2026-02-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-02-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-02-04 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-07-23 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2026-02-04 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-02-04 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-02-04 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2026-02-04 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-12-31 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2019-12-31 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-02-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-02-04 |
| PML | Bone Cement, Posterior Screw Augmentation | Orthopedic | Class 2 | 888.3027 | 2025-07-23 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-07-23 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-07-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-02-04 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2026-02-04 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2025-07-23 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-02-04 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2020-03-17 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-18 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-07-23 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-07-23 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-07-23 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-07-23 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-12-31 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-12-31 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-02-04 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2026-02-04 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-02-04 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-02-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-02-04 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-12-21 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2018-12-21 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2026-02-04 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-02-04 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-02-04 |
| PML | Bone Cement, Posterior Screw Augmentation | Orthopedic | Class 2 | 888.3027 | 2026-02-04 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-02-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-07-23 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-07-23 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-07-23 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2017-12-28 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2017-12-28 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2017-12-28 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2017-12-28 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2017-12-28 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2017-12-28 |
| OWI | Bone Fixation Cerclage, Sublaminar | Orthopedic | Class 2 | 888.3010 | 2025-07-23 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2017-12-21 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-12-31 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2019-12-31 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2019-12-31 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2019-12-31 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2019-12-31 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-12-31 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-02-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-02-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-07-23 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-02-04 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-02-04 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-02-04 |
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | Class 2 | 870.1025 | 2022-01-20 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-20 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| BSK | Cuff, Tracheal Tube, Inflatable | Anesthesiology | Class 2 | 868.5750 | 2026-02-04 |
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | Class 2 | 874.1820 | 2026-02-04 |
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | Class 2 | 868.5730 | 2026-02-04 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-01-30 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-01-20 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2022-01-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2022-01-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-01-20 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2025-07-23 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2019-01-18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-18 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2019-01-18 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3043543260 | FERRY MACHINE CORPORATION | Oakland, NJ, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K010427 | Walter Lorenz Surgical, Inc. | LORENZ FIDUCAIL SCREW | 2001-03-15 |
| K812744 | Progress Mankind Technology | LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER | 1981-12-03 |
| K092467 | Brainlab AG | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED | 2010-05-06 |
| K031454 | Biomet, Inc. | ACUMEN SURGICAL NAVIGATION SYSTEM | 2004-07-08 |
| K260601 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | 2026-03-26 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0001-2012 | Medtronic Navigation, Inc | 2 | Probe, Tactile, Left, ASM, Long,
Part #962009S,
Medtronic Navigation,
Louisville, CO 80027.
Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. |
| Z-0002-2012 | Medtronic Navigation, Inc | 2 | Probe, Tactile, Right, ASM, Long,
Part #962011S,
Medtronic Navigation,
Louisville, CO 80027.
Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. |
| Z-0005-2007 | Stryker Instruments Div. of Stryker Corporation | 2 | Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000. |
| Z-0006-2007 | Stryker Instruments Div. of Stryker Corporation | 2 | Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1417592 | MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, US |
| 8010916 | Kammerer Medical Systems GmbH & Co. KG | Stockach Baden-Wurttemberg, DE |
| 3007689689 | ELOS MEDTECH PINOL A/S | Goerloese Hovedstaden, DK |
| 1038671 | EXACTECH, INC. | GAINESVILLE, FL, US |
| 3009582259 | Li Wai Precision International Limited | Tsimshatsui, Kowloon, HK |
3009959868 when referencing this establishment in official correspondence.