FDA 510(k) Application Details - K962616

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K962616
Device Name	Plate, Fixation, Bone
Applicant	SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	ANGELA J SILVESTRI Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/1996
Decision Date	09/03/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review