510(k) K180118 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Arthrex NanoSuture Anchor
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Feb 12, 2018 |
| Received | Jan 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180118
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2018 | Arthrex, Inc. Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT
Product Usage:
Soft tissue fixation to bone in Open, Classified |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.