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FDA 510(k) Application Details - K011495
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
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510(K) Number
K011495
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES, FL 34104 US
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Contact
ANN WATERHOUSE
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Regulation Number
888.3030
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Classification Product Code
MAI
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More FDA Info for this Product Code
Date Received
05/15/2001
Decision Date
08/01/2001
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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