FDA 510(k) Application Details - K963402

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K963402
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	INNOVASIVE DEVICES, INC. 734 FOREST ST. MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	ERIC BANNON 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	08/29/1996
Decision Date	11/04/1996
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