510(k) K141735 ยท HRS Plate, Fixation, Bone
ARTHREX ANKLE FUSION PLATING SYSTEM
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Aug 15, 2014 |
| Received | Jun 27, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141735
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Arthrex, Inc. Low Profile Screw, 4.5 x 20 mm
The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixati Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.