FDA 510(k) Application Details - K071090

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

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510(K) Number K071090
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant ZIMMER TRABECULAR METAL TECHNOLOGY
10 POMEROY RD.
PARSIPPANY, NJ 07054 US
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Contact KATHLEEN RUTHERFORD
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Regulation Number 888.3660

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Classification Product Code KWS
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Date Received 04/18/2007
Decision Date 06/29/2007
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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