The following data is part of a premarket notification filed by Treace Medical Concepts, Inc. with the FDA for Treace Medical Concepts (tmc) Plating System.
| Device ID | K153531 |
| 510k Number | K153531 |
| Device Name: | Treace Medical Concepts (TMC) Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | TREACE MEDICAL CONCEPTS, INC. 3107 SAWGRASS VILLAGE CIRCLE Ponte Vedra Beach, FL 32082 |
| Contact | Joe Ferguson |
| Correspondent | Kimberly Strohkirch MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-09 |
| Decision Date | 2016-01-07 |
| Summary: | summary |