The following data is part of a premarket notification filed by Treace Medical Concepts, Inc. with the FDA for Treace Medical Concepts (tmc) Compression Screw System.
| Device ID | K172617 |
| 510k Number | K172617 |
| Device Name: | Treace Medical Concepts (TMC) Compression Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Treace Medical Concepts, Inc. 3107 Sawgrass Village Circle Ponte Vedra Beach, FL 32082 |
| Contact | Rachel Osbeck |
| Correspondent | Dawn Norman MRC/X 6075 Poplar Avenue Suite 500 Memphis, TN 38119 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-31 |
| Decision Date | 2017-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853114006112 | K172617 | 000 |
| 00853114006075 | K172617 | 000 |
| 00853114006068 | K172617 | 000 |
| 00853114006198 | K172617 | 000 |
| 00853114006174 | K172617 | 000 |