K183363 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Snap-Off Screw System. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Treace Medical Concepts, Inc. (Ponte Vedra, US). The FDA issued a Cleared decision on June 13, 2019, 191 days after receiving the submission on December 4, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K183363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2018 |
| Decision Date | June 13, 2019 |
| Days to Decision | 191 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 |