FDA 510(k) Application Details - K150715

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K150715
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	TORNIER, INC. 10801 NESBITT AVENUE SOUTH BLOOMINGTON, MN 55437 US Other 510(k) Applications for this Company
Contact	Kaitlyn Rainbow 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	03/19/2015
Decision Date	07/28/2015
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