FDA 510(k) Application Details - K161587

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K161587
Device Name	Staple, Fixation, Bone
Applicant	AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT 212 COPPERWOOD COURT MILLERSVILLE, MD 21108 US Other 510(k) Applications for this Company
Contact	AL AUSTIN Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2016
Decision Date	02/01/2017
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