510(k) K031666 ยท HRS Plate, Fixation, Bone
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Nov 18, 2003 |
| Received | May 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031666
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2016 | Arthrex, Inc. Arthrex Deltoid Ligament Reconstruction Implant System.
Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titaniu Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.