The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Anatomical Plating System.
| Device ID | K193222 |
| 510k Number | K193222 |
| Device Name: | Tyber Medical Anatomical Plating System |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-22 |
| Decision Date | 2020-01-20 |