FDA 510(k) Application Details - K153215

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K153215
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant	Custom Orthopaedic Solutions, Inc. 10000 Cedar Avenue Cleveland, OH 44106 US Other 510(k) Applications for this Company
Contact	Keith Grafmeyer 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	11/05/2015
Decision Date	02/19/2016
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