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FDA 510(k) Application Details - K181555
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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510(K) Number
K181555
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
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Contact
David L. Rogers
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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
06/13/2018
Decision Date
12/21/2018
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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