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FDA 510(k) Application Details - K130129
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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510(K) Number
K130129
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
ARTHREX, INC.
1370 Creekside Blvd
Naples, FL 34108 US
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Contact
COURTNEY SMITH
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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
01/17/2013
Decision Date
05/31/2013
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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