FDA 510(k) Application Details - K102670

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K102670
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant	SHOULDER INNOVATIONS, LLC 4670 FULTON STREET EAST SUITE 202 ADA, MI 49301 US Other 510(k) Applications for this Company
Contact	ANDREW RODENHOUSE 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	09/16/2010
Decision Date	01/24/2011
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