510(k) K964404 ยท KWP Appliance, Fixation, Spinal Interlaminal
BACFIX SPINAL FIXATION SYSTEM
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Mar 26, 1997 |
| Received | Nov 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Spinal Concepts, Inc 955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.