FDA 510(k) Application Details - K170868

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K170868
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	S.B.M SAS Science for Bio Materials ZI du Monge Lourdes 65100 FR Other 510(k) Applications for this Company
Contact	Anne Cospin-Latapie Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2017
Decision Date	11/30/2017
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