510(k) K130438 ยท PEK Spinous Process Plate
AXLE INTERSPINOUS FUSION SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Jun 27, 2013 |
| Received | Feb 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2021 | XTANT Medical X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. Terminated |
PEK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.