510(k) K972183 ยท HSB Rod, Fixation, Intramedullary And Accessories
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
| Applicant | Ace Medical Co., El Segundo CA, US |
| Decision | Substantially Equivalent, Aug 26, 1997 |
| Received | Jun 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972183
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2018 | Zimmer Biomet, Inc. AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE
800508270 NAIL TIB DYN 08X27.0 - STERILE
800508285 NAIL TIB DYN 08X28.5 - STERILE
8005083 Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5
810508270 NAIL TIB DYN 08 X 27.0
810508285 NAIL TIB DYN 08 X 28.5
810508300 NAIL TIB DYN 08 X Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.