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FDA 510(k) Application Details - K221366
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K221366
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
WishBone Medical, Inc.
100 Capital Drive
Warsaw, IN 46582 US
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Contact
Ramakrishna Bajaj
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
05/12/2022
Decision Date
06/06/2022
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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