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FDA 510(k) Application Details - K070555
Device Classification Name
Pin, Fixation, Smooth
More FDA Info for this Device
510(K) Number
K070555
Device Name
Pin, Fixation, Smooth
Applicant
ORTHOPRO LLC
13115 NE 4TH ST., SUITE 130
VANCOUVER, WA 98684 US
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Contact
CHRISTOPHER COOK
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HTY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/27/2007
Decision Date
07/13/2007
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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