FDA 510(k) Application Details - K052913

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K052913
Device Name Filler, Bone Void, Calcium Compound
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 888.3045

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Classification Product Code MQV
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Date Received 10/17/2005
Decision Date 11/07/2005
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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