FDA 510(k) Application Details - K153180

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K153180
Device Name	Screw, Fixation, Bone
Applicant	TYBER MEDICAL LLC 89 HEADQUARTERS PLAZA NORTH #1464 MORRISTOWN, NJ 07960 US Other 510(k) Applications for this Company
Contact	Mark F. Schenk Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2015
Decision Date	11/25/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review