FDA 510(k) Application Details - K010121

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K010121
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	SYNTHES (USA) 1690 RUSSELL RD. PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	THOMAS M MAGUIRE Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2001
Decision Date	02/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review