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FDA 510(k) Application Details - K171606
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
More FDA Info for this Device
510(K) Number
K171606
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant
Advanced Orthopaedic Solutions, Inc. (AOS)
3203 Kashiwa Street
Torrance, CA 90505 US
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Contact
Alex Bhaskarla
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2017
Decision Date
06/22/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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