510(k) K032812 ยท MQP Spinal Vertebral Body Replacement Device
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
| Applicant | Orthovita, Inc., Malver PA, US |
| Decision | Substantially Equivalent, Dec 8, 2003 |
| Received | Sep 9, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2012 | TITAN SPINE, LLC Titan Spine Endoskeleton TA Implant products.
2107-0118 18mm Standard Endoskeleton Implant VBR
2107-0120 20mm Standard Endoskeleton Implant VBR
2107-0218 18mm Large Endoskeleton Implant VBR
2107-02 Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.