FDA 510(k) Application Details - K142942

Device Classification Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented   More FDA Info for this Device
510(K) Number	K142942
Device Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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	888.3690   More FDA Info for this Regulation Number
Classification Product Code	HSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2014
Decision Date	12/19/2014
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