510(k) K131591 ยท HWC Screw, Fixation, Bone
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
| Applicant | Pega Medical, Inc., Laval, CA |
| Decision | Substantially Equivalent, Nov 27, 2013 |
| Received | May 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2015 | Pega Medical Inc. SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System.
This instrument is included in the Free Gliding SCFE Screw System instrument tray. This Terminated |
HWC | None listed |
| Jun 26, 2015 | Pega Medical Inc. Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.