FDA 510(k) Application Details - K152527

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K152527
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	Jayana Kenana 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	09/03/2015
Decision Date	10/29/2015
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