510(k) K203495 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Arthrex SwiveLock Anchor
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Apr 19, 2021 |
| Received | Nov 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2021 | Arthrex, Inc. Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC Open, Classified |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.