FDA 510(k) Application Details - K162153

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K162153
Device Name	Screw, Fixation, Bone
Applicant	ASCENSION ORTHOPEDICS 8700 CAMERON ROAD, SUITE 100 AUSTIN, TX 78754 US Other 510(k) Applications for this Company
Contact	GABRIELLA BECKER 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	08/02/2016
Decision Date	07/14/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review