FDA 510(k) Application Details - K112285

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

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510(K) Number K112285
Device Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant TGM MEDICAL, INC.
5145 Golden Foothill Parkway
Suite 175 & 180
El Dorado Hills, CA 95762 US
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Contact DENNIS H CRANE
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Regulation Number 888.3560

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Classification Product Code JWH
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Date Received 08/09/2011
Decision Date 11/04/2011
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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