510(k) K103034 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
GENESYS SPINE INTERBODY FUSION SYSTEM
| Applicant | Genesys Spine, Austin TX, US |
| Decision | Substantially Equivalent, Dec 10, 2010 |
| Received | Oct 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2012 | Genesys Orthopedic Systems, LLC Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System.
The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patien Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.