510(k) K983258 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Oct 21, 1998 |
| Received | Sep 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983258
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Spinal Concepts, Inc 955-5 BackFix Coldwelder II with straight tip 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.