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FDA 510(k) Application Details - K211112
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K211112
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
Orthopaedic Implant Company
770 Smithridge Dr. #400
Reno, NV 89502 US
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Contact
Douglas Fulton
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
04/14/2021
Decision Date
05/05/2021
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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