510(k) K123347 ยท HRS Plate, Fixation, Bone
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
| Applicant | Normed Medizin-Technik GmbH, Austin TX, US |
| Decision | Substantially Equivalent, Aug 2, 2013 |
| Received | Oct 31, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123347
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2019 | Zimmer GmbH Drill, 2.7x125mm, AO, Item Number 502015217 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 3.2x145mm, AO, Item Number 502015650 Terminated |
HTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.