FDA 510(k) Application Details - K152454

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K152454
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
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	888.3730   More FDA Info for this Regulation Number
Classification Product Code	KWD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2015
Decision Date	04/11/2016
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