The following data is part of a premarket notification filed by Treace Medical Concepts, Inc. with the FDA for Python Plate Trial Instruments.
| Device ID | K173930 |
| 510k Number | K173930 |
| Device Name: | PYTHON Plate Trial Instruments |
| 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 MRC-X, LLC. 203 Fort Wade Rd. Suite 150 Ponte Vedra, FL 32081 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-03-19 |
| Summary: | summary |