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FDA 510(k) Application Details - K110905
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
More FDA Info for this Device
510(K) Number
K110905
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
SHOULDER INNOVATIONS, LLC
4670 FULTON STREET EAST
ADA, MI 49301 US
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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
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More FDA Info for this Product Code
Date Received
03/31/2011
Decision Date
05/24/2011
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
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