510(k) K011583 ยท HTN Washer, Bolt Nut
SPIKED WASHER
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jan 30, 2002 |
| Received | May 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011583
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2013 | Synthes USA HQ, Inc. Synthes Spiked Washers 13.5/6.5
Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments. Terminated |
HTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.