510(k) K021564 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
INCOMPASS SPINAL FIXATION SYSTEM
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Oct 25, 2002 |
| Received | May 13, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021564
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2008 | Abbott Spine InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727. Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.