FDA 510(k) Application Details - K151256

Device Classification Name	More FDA Info for this Device
510(K) Number	K151256
Device Name	Arthrex BioSync« Bone Wedge
Applicant	Arthex, Inc 1370 Creekside Boulevard Naples, FL 34108 US Other 510(k) Applications for this Company
Contact	Laura Medlin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2015
Decision Date	08/12/2015
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