FDA 510(k) Application Details - K021489

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

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510(K) Number K021489
Device Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact EHAB M ESMAIL
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Regulation Number 888.3510

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Classification Product Code KRO
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Date Received 05/08/2002
Decision Date 12/04/2002
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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