The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Mst Trauma Screw.
Device ID | K153180 |
510k Number | K153180 |
Device Name: | Tyber Medical MST 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-03 |
Decision Date | 2015-11-25 |
Summary: | summary |