510(k) K003397 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
COLLES C SERIES FRAME STERILE PACK
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 29, 2001 |
| Received | Nov 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003397
| 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.