510(k) K143355 ยท HSB Rod, Fixation, Intramedullary And Accessories
The Simple Locking IntraMedullary (SLIM) System
| Applicant | Pega Medical, Inc., Laval, CA |
| Decision | Substantially Equivalent, Jul 10, 2015 |
| Received | Nov 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2019 | Pega Medical Inc. SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.