510(k) K080537 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
L-VARLOCK
| Applicant | Kiscomedica S.A., Round Rock TX, US |
| Decision | Substantially Equivalent, Jun 30, 2008 |
| Received | Feb 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080537
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2017 | Kiscomedica S.A. L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France.
Product Usage:
The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally matur Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.