FDA 510(k) Application Details - K112583

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K112583
Device Name	Screw, Fixation, Bone
Applicant	SYNTHES (USA) PRODUCTS LLC 1303 GOSHEN PARKWAY WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	REBECCA BLANK 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	09/06/2011
Decision Date	12/05/2011
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