FDA Device Registration & Listing · Souderton, PA, US · Registration 3010032903
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | Class 2 | 876.5665 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| OWI | Bone Fixation Cerclage, Sublaminar | Orthopedic | Class 2 | 888.3010 | 2026-04-14 |
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | Class 2 | 870.1025 | 2026-04-14 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-04-14 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-04-14 |
| PEK | Spinous Process Plate | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-04-14 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| PML | Bone Cement, Posterior Screw Augmentation | Orthopedic | Class 2 | 888.3027 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| PEK | Spinous Process Plate | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| OWI | Bone Fixation Cerclage, Sublaminar | Orthopedic | Class 2 | 888.3010 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2026-04-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2026-04-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2026-04-14 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-04-14 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K032752 | R&B Surgical Solutions, LLC | R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM | 2003-12-03 |
| K062643 | Life Spine | KINETIC ANTERIOR CERVICAL PLATE | 2006-11-16 |
| K081051 | Spine View, Inc. | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE | 2008-08-07 |
| K820777 | The Anspach Effort, Inc. | MINI-MICRO ARTHROSCOPIC SCAPEL | 1982-05-12 |
| K963639 | Acromed Corp. | ACROMED PEDICLE SCREW | 1996-11-14 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0036-2013 | Medtronic Sofamor Danek USA Inc | 2 | ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
| Z-0037-2013 | Medtronic Sofamor Danek USA Inc | 2 | ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
| Z-0038-2013 | Medtronic Sofamor Danek USA Inc | 2 | PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
| Z-0040-05 | Zimmer Spine, Inc. | 2 | ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays. |
| Z-0041-05 | Linvatec Corp. | 2 | Ultra Power Burs, Sterile, Single-Use. |
| 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 |
3010032903 when referencing this establishment in official correspondence.