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FDA 510(k) Application Details - K161417
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K161417
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
SYNTHES USA, LLC
1301 GOSHEN PARKWAY
WEST CHESTER, PA 19380 US
Other 510(k) Applications for this Company
Contact
STACEY BONNELL
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2016
Decision Date
11/10/2016
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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