FDA 510(k) Application Details - K083151

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K083151
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	JAMY GANNOE 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	10/24/2008
Decision Date	01/22/2009
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