The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Incore Tmt System.
| Device ID | K192578 |
| 510k Number | K192578 |
| Device Name: | InCore TMT System |
| Classification | Screw, Fixation, Bone |
| Applicant | Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580 |
| Contact | Elise Fox |
| Correspondent | Elise Fox Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-19 |
| Decision Date | 2019-12-31 |
| Summary: | summary |