FDA 510(k) Application Details - K131635

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K131635
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	GAIL SCHROEDER 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	06/04/2013
Decision Date	08/29/2013
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