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FDA 510(k) Application Details - K150655
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K150655
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
ORTHOPAEDIC IMPLANT COMPANY
316 CALIFORNIA AVE
#701
RENO, NV 89509 US
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Contact
Douglas Fulton
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Regulation Number
888.3020
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Classification Product Code
HSB
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More FDA Info for this Product Code
Date Received
03/13/2015
Decision Date
07/09/2015
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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