510(k) K081244 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
| Applicant | Biomet Trauma, Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 30, 2008 |
| Received | May 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081244
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | Zimmer Biomet, Inc. HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit)
Item Nos: HAA60-09030
HAA60-09040
HAA60-10030
HAA60-10040
HAA60-11030
HAA60-11040
HAA60-11050
HAA60-12040
HAA60-12060 Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.