510(k) K231278 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Knotless Suture Anchor
| Applicant | Riverpoint Medical, LLC, Portland OR, US |
| Decision | Substantially Equivalent, Aug 1, 2023 |
| Received | May 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2023 | Riverpoint Medical, LLC Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520
Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521
The Iconix Knotless anchors are intended to be use Open, Classified |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.