FDA 510(k) Application Details - K092914

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K092914
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	MEDSHAPE SOLUTIONS 1575 NORTHSIDE DR. SUITE 440 ATLANTA, GA 30318 US Other 510(k) Applications for this Company
Contact	JACK GRIFFIS 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	09/22/2009
Decision Date	12/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review