FDA 510(k) Application Details - K060017

Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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510(K) Number K060017
Device Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Applicant MAKO SURGICAL CORP.
2901 SIMMS STREET
HOLLYWOOD, FL 33020 US
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Contact WILLIAM F TAPIA
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Regulation Number 888.3520

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Classification Product Code HSX
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Date Received 01/04/2006
Decision Date 02/23/2006
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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