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 | K183321 |
| 510k Number | K183321 |
| Device Name: | Treace Medical Concepts (TMC) Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Treace Medical Concepts, Inc. 203 Fort Wade Rd., Suite 150 Ponte Vedra, FL 32081 |
| Contact | Rachel Osbeck |
| Correspondent | Dawn Norman Memphis Regulatory Consulting, LLC 6075 Poplar Avenue, Suite 500 Memphis, TN 38119 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-30 |
| Decision Date | 2019-01-25 |
| Summary: | summary |