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FDA 510(k) Application Details - K193157
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K193157
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
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Contact
Jessica L. Singelais
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
MAI
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More FDA Info for this Product Code
Date Received
11/14/2019
Decision Date
12/12/2019
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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