510(k) K103655 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jun 30, 2011 |
| Received | Dec 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2012 | Exactech, Inc. Octane-C Cervical, 6 Lordotic
Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7). Terminated |
ODP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.