510(k) K181083 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Stryker All-PEEK Knotless Anchor System
| Applicant | Stryker, San Jose CA, US |
| Decision | Substantially Equivalent, Jul 23, 2018 |
| Received | Apr 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2020 | Stryker Corporation Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197 Terminated |
MBI | None listed |
| Mar 2, 2020 | Stryker Corporation Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197 Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.