510(k) K141478 ยท HRS Plate, Fixation, Bone
ARTHREX FRACTURE PLATES AND SCREWS
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Jul 8, 2014 |
| Received | Jun 4, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141478
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2020 | Arthrex, Inc. Sterile Low Profile Screw, Titanium, 6.7 x 65mm
Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation fo Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.