The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Bioty® Nanotopography Trauma Screw.
| Device ID | K161597 |
| 510k Number | K161597 |
| Device Name: | Tyber Medical BioTy® Nanotopography Trauma Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 Morristown, NJ 07960 |
| Contact | Mark F. Schenk |
| Correspondent | Mark F. Schenk TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 Morristown, NJ 07960 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-09 |
| Decision Date | 2016-11-16 |
| Summary: | summary |