FDA 510(k) Application Details - K151701

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K151701
Device Name	Screw, Fixation, Bone
Applicant	NORMED MEDIZIN-TECHNIK GMBH ULRICHSTRASSE 7 TUTTLINGEN D-78532 DE Other 510(k) Applications for this Company
Contact	ARNE BRIEST 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	06/24/2015
Decision Date	01/26/2016
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