FDA Device Registration & Listing · CLEVELAND, OH, US · Registration 1528646
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2014-01-31 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2014-01-31 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2014-01-31 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-01-31 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-01-31 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2011-06-14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2011-06-14 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2011-06-14 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2014-01-31 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2014-01-31 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2014-01-31 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2014-01-31 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2014-01-31 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-01-31 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-01-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2014-01-31 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2014-01-31 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2014-01-31 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2014-01-31 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2014-01-31 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-01-31 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2014-01-31 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2014-01-31 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-01-31 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2014-01-31 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-01-10 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | Class 2 | 882.4800 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-01-10 |
No US Agent registered (Local establishment).
| 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 |
| K012175 | Encore Orthopedics, Inc. | PASS SPINAL SYSTEM | 2001-07-31 |
| K032752 | R&B Surgical Solutions, LLC | R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM | 2003-12-03 |
| 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 |
1528646 when referencing this establishment in official correspondence.