FDA 510(k) Application Details - K170388

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K170388
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Summit Medical Ltd. Bourton Industrial Park Bourton on the Water GL54 2HQ GB Other 510(k) Applications for this Company
Contact	Sam Drew 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	02/08/2017
Decision Date	07/25/2017
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