FDA 510(k) Application Details - K960516

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K960516
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	ARTHREX, INC. 3050 NORTH HORSESHOE DR., SUITE 200 NAPLES, FL 33942 US Other 510(k) Applications for this Company
Contact	SCOTT M DURLACHER 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	02/05/1996
Decision Date	04/18/1996
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