FDA 510(k) Application Details - K180118

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K180118
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-5553 US Other 510(k) Applications for this Company
Contact	Rebecca R. Homan 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	01/16/2018
Decision Date	02/12/2018
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