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FDA 510(k) Application Details - K170326
Device Classification Name
Pin, Fixation, Smooth
More FDA Info for this Device
510(K) Number
K170326
Device Name
Pin, Fixation, Smooth
Applicant
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
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Contact
Howard L. Schrayer
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HTY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/2017
Decision Date
07/20/2017
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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