K131591 is an FDA 510(k) clearance for the FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE). This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Pega Medical, Inc. (Laval, CA). The FDA issued a Cleared decision on November 27, 2013, 180 days after receiving the submission on May 31, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K131591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2013 |
| Decision Date | November 27, 2013 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC - Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |