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FDA 510(k) Application Details - K170206
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K170206
Device Name
Cerclage, Fixation
Applicant
ARTHREX, INC.
1370 CREEKSIDE BOULEVARD
NAPLES, FL 34108-1945 US
Other 510(k) Applications for this Company
Contact
IVETTE GALMEZ
Other 510(k) Applications for this Contact
Regulation Number
888.3010
More FDA Info for this Regulation Number
Classification Product Code
JDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/24/2017
Decision Date
11/15/2017
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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