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FDA 510(k) Application Details - K172371
Device Classification Name
More FDA Info for this Device
510(K) Number
K172371
Device Name
Arthrex UNIVERS REVERS COATED BASEPLATE
Applicant
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 US
Other 510(k) Applications for this Company
Contact
Courtney Smith
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/07/2017
Decision Date
03/22/2018
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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