FDA 510(k) Application Details - K973381

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K973381
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	INNOVASIVE DEVICES, INC. 734 FOREST ST. MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	STEPHEN M PAGE Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/1997
Decision Date	02/18/1998
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