510(k) K211002 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Grappler Suture Anchor System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Jul 7, 2021 |
| Received | Apr 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2022 | Paragon 28, Inc. Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System Open, Classified |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.