The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Trauma Screw.
| Device ID | K192974 |
| 510k Number | K192974 |
| Device Name: | Tyber Medical Trauma Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | Tyber Medical LLC 83 South Commerce Way, Suite 310 Bethlehem, PA 18017 |
| Contact | Mark Schenk |
| Correspondent | Jessica Stigliano Tyber Medical LLC 83 South Commerce Way, Suite 310 Bethlehem, PA 18017 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-24 |
| Decision Date | 2020-01-08 |