FDA 510(k) Application Details - K151500

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K151500
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant	CUSTOM ORTHOPAEDIC SOLUTIONS 10000 CEDAR AVE CLEVELAND, OH 44106 US Other 510(k) Applications for this Company
Contact	Peter D O'Neill Other 510(k) Applications for this Contact
Regulation Number	888.3660   More FDA Info for this Regulation Number
Classification Product Code	KWS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2015
Decision Date	10/05/2015
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