510(k) K111232 ยท HSB Rod, Fixation, Intramedullary And Accessories
GAP ENDO-EXO MEDULLARY SYSTEM
| Applicant | Pega Medical, Inc., Laval, CA |
| Decision | Substantially Equivalent, Jan 26, 2012 |
| Received | May 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2015 | Pega Medical Inc. GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28.
Product Usage:
The GAP Endo-Exo Medullary System is used for the t Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.