FDA 510(k) Application Details - K061223

Device Classification Name Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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510(K) Number K061223
Device Name Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact THERESA LEISTER
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Regulation Number 888.3565

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Classification Product Code MBH
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Date Received 05/02/2006
Decision Date 08/18/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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