The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Trauma Screw.
Device ID | K133842 |
510k Number | K133842 |
Device Name: | TYBER MEDICAL TRAUMA SCREW |
Classification | Screw, Fixation, Bone |
Applicant | TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 Morristown, NJ 07960 |
Contact | Jeff Tyber |
Correspondent | Jeff Tyber 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 | 2013-12-18 |
Decision Date | 2014-03-20 |
Summary: | summary |