FDA 510(k) Application Details - K170440

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K170440
Device Name	Washer, Bolt Nut
Applicant	Arthrosurface, Inc 28 Forge Parkway Franklin, MA 02038 US Other 510(k) Applications for this Company
Contact	Dawn J. Wilson Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2017
Decision Date	05/03/2017
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