510(k) K003496 ยท HTN Washer, Bolt Nut
CANNULATED SCREW SYSTEM
| Applicant | Pioneer Surgical Technology, Marquette MI, US |
| Decision | Substantially Equivalent, Feb 8, 2001 |
| Received | Nov 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2006 | Pioneer Surgical Technology Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.