510(k) K050553 ยท MQP Spinal Vertebral Body Replacement Device
NOVEL VBR SPINAL SYSTEM
| Applicant | Alphatec/Nexmed, Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 18, 2005 |
| Received | Mar 3, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2008 | Alphatec Spine, Inc. Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126.
Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebra Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.