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FDA 510(k) Application Details - K012788
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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510(K) Number
K012788
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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DAVID HENLEY
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Regulation Number
888.3660
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Classification Product Code
KWS
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More FDA Info for this Product Code
Date Received
08/20/2001
Decision Date
03/15/2002
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
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