FDA 510(k) Application Details - K953954

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K953954
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	LINVATEC CORP. 11311 CONCEPT BLVD. LARGO, FL 33773-4908 US Other 510(k) Applications for this Company
Contact	CAROL A WEIDEMAN 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	08/22/1995
Decision Date	02/20/1996
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