The following data is part of a premarket notification filed by Treace Medical Concepts, Inc. with the FDA for Treace Medical Concepts (tmc) Screw Fixation System.
| Device ID | K213036 |
| 510k Number | K213036 |
| Device Name: | Treace Medical Concepts (TMC) Screw Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | Treace Medical Concepts, Inc. 203 Fort Wade Rd., Suite 150 Ponte Vedra, FL 32081 |
| Contact | Kristina Hall |
| Correspondent | Danielle Besal MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2021-10-21 |