FDA 510(k) Application Details - K100370

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

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510(K) Number K100370
Device Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant SIGNAL MEDICAL CORP.
1000 DES PERES ROAD
SUITE 140
ST. LOUIS, MO 63131 US
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Contact BRIAN KATERBERG
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Regulation Number 888.3560

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Classification Product Code JWH
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Date Received 02/12/2010
Decision Date 03/07/2011
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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