510(k) K032187 ยท HRS Plate, Fixation, Bone
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Sep 22, 2003 |
| Received | Jul 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2021 | Arthrex, Inc. Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.