FDA Device Registration & Listing · Renquishausen Baden-Wurttemberg, DE · Registration 3023852420
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-25 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2025-01-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-03-05 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2020-03-05 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2020-03-05 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2020-12-08 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2019-09-12 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2019-09-12 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2022-12-07 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-12-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2022-12-07 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-01-03 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-03-24 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2025-03-24 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-03-24 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | Class 2 | 882.1870 | 2025-03-24 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | Class 2 | 890.1375 | 2025-03-24 |
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | Class 2 | 874.1820 | 2025-03-24 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2014-11-08 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | Class 2 | 882.4310 | 2012-12-13 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-12-18 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2010-02-16 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-01-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-01-25 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-01-25 |
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | Class 2 | 882.1620 | 2017-11-09 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2021-03-02 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-03-02 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2024-01-16 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-01-16 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2024-01-03 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-01-03 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-02-14 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-02-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-01-25 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-01-25 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2020-12-08 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2020-12-08 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2026-05-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-07-21 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2025-12-27 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2020-09-01 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-09-01 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2020-12-08 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-01-25 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2025-01-25 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2015-09-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-25 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2014-03-08 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-05-01 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2026-04-16 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-05-30 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-05-30 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-05-30 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2020-12-08 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2014-03-10 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2020-11-06 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-07-21 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2025-01-25 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2025-12-27 |
| EOX | Esophagoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4710 | 2025-01-21 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-01-10 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2022-11-23 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-27 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-25 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-25 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-01-21 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-03-23 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2022-03-23 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2024-03-10 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2020-12-08 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2020-12-08 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2022-03-08 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-03-08 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2017-12-15 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2013-12-17 |
| HTT | Burr, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2021-02-10 |
| JEC | Component, Traction, Invasive | Orthopedic | Class 2 | 888.3040 | 2020-03-26 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-07-30 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-25 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-25 |
| HWW | Countersink | Orthopedic | Class 1 | 888.4540 | 2019-10-14 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-03-11 |
| HXO | Pusher, Socket | Orthopedic | Class 1 | 888.4540 | 2021-03-11 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2024-07-25 |
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | Class 2 | 882.1620 | 2017-11-09 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2020-07-09 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-07-30 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-25 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-10-18 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-25 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2025-01-25 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2025-01-25 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-07-30 |
| LXI | Guide, Drill, Ligament | General, Plastic Surgery | Class 1 | 878.4820 | 2022-02-10 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2015-12-20 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2009-03-19 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2016-10-27 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-25 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2025-01-25 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Neurology | Class 2 | 882.4300 | 2016-05-06 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2020-12-08 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-25 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-27 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-01-25 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-01-25 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-01-29 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-01-29 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2020-07-09 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2020-07-09 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2020-07-09 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2020-07-09 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2020-07-09 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-02-18 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2014-07-10 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2019-07-11 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2019-07-11 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2020-12-08 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2020-10-14 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2015-12-10 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2019-07-11 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2020-07-09 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2020-07-09 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2020-07-09 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2020-07-09 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2020-07-09 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2020-07-09 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-07-09 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2020-07-09 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2020-07-09 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2020-07-09 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Orthopedic | Class 2 | 888.3353 | 2020-07-09 |
| HXJ | Staple Driver | Orthopedic | Class 1 | 888.4540 | 2025-12-01 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-12-23 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-12-23 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Dental | Class 2 | 872.4120 | 2018-12-13 |
| DZI | Drill, Bone, Powered | Dental | Class 2 | 872.4120 | 2018-12-13 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2025-01-25 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2021-03-18 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2019-06-24 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2019-06-24 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K963639 | Acromed Corp. | ACROMED PEDICLE SCREW | 1996-11-14 |
| K032604 | Co-Ligne AG | GII SPINAL FIXATION SYSTEM | 2004-01-20 |
| K964304 | Osteonics Corp. | OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY | 1997-01-17 |
| K163363 | Surgtech, Inc. | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System | 2017-04-05 |
| K252461 | Spinal Resources, Inc. | Swedge Pedicle Screw Fixation System Bezier Rod | 2026-01-13 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0026-2011 | Zimmer Inc. | 2 | SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S |
| Z-0027-2011 | Zimmer Inc. | 2 | SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M |
| Z-0028-2011 | Zimmer Inc. | 2 | SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L |
| Z-0029-2011 | Zimmer Inc. | 2 | SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL |
| Z-0030-2011 | Zimmer Inc. | 2 | SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S |
| 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 |
3023852420 when referencing this establishment in official correspondence.