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FDA 510(k) Application Details - K170482
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K170482
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S
Demirkapi Topcular Mahallesi Topcular Caddesi Set Ustu No:3
Istanbul TR 34055 TR
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Contact
Sumru Alperen
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
02/16/2017
Decision Date
09/27/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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