K151838 is an FDA 510(k) clearance for the PRO-TOE Hammertoe Fixation System. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on September 4, 2015, 60 days after receiving the submission on July 6, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K151838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2015 |
| Decision Date | September 04, 2015 |
| Days to Decision | 60 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 |