The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Soft Grip Uni-handle.
| Device ID | K823913 |
| 510k Number | K823913 |
| Device Name: | SOFT GRIP UNI-HANDLE |
| Classification | Handle, Instrument, Dental |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-28 |
| Decision Date | 1983-01-26 |