510(k) K191287 · GDW Staple, Implantable
OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners
| Applicant | Davol Inc., Subsidiary of C.R. Bard, Warwick RI, US |
| Decision | Substantially Equivalent, Jul 16, 2019 |
| Received | May 13, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191287
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.