510(k) K152312 ยท HRS Plate, Fixation, Bone
RECON system-V-TEK-IVP Plates and Screws
| Applicant | Normed Medizin-Technik GmbH, Tuttlingen, DE |
| Decision | Substantially Equivalent, Oct 30, 2015 |
| Received | Aug 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2019 | Zimmer GmbH V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638 Terminated |
HTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.