510(k) K061808 ยท HRS Plate, Fixation, Bone
DARCO LOCKING BONE PLATE SYSTEM
| Applicant | Darco International, Inc., Huntington WV, US |
| Decision | Substantially Equivalent, Aug 17, 2006 |
| Received | Jun 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2022 | Wright Medical Technology, Inc. The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The dr Terminated |
HRS | None listed |
| Dec 3, 2021 | Wright Medical Technology Inc Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. Open, Classified |
HRS | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.