FDA 510(k) Application Details - K131129

Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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510(K) Number K131129
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant ZIMMER CAS
1800 WEST CENTER STREET
WARSAW, IN 46580 US
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Contact JASON HECKAMAN
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Regulation Number 888.3660

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Classification Product Code KWS
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Date Received 04/22/2013
Decision Date 08/20/2013
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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