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FDA 510(k) Application Details - K964786
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
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510(K) Number
K964786
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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CRISTIE MANUEL
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Regulation Number
888.3040
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Classification Product Code
MBI
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More FDA Info for this Product Code
Date Received
11/29/1996
Decision Date
02/06/1997
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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