510(k) K080699 ยท MQP Spinal Vertebral Body Replacement Device
NOVEL SPINAL SPACER SYSTEM
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, May 21, 2008 |
| Received | Mar 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080699
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2009 | Alphatec Spine, Inc. Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124.
Spinal fixation system consistin Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.