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FDA 510(k) Application Details - K201362
Device Classification Name
More FDA Info for this Device
510(K) Number
K201362
Device Name
CD HorizonÖ Fenestrated Screw Set, CD HorizonÖ Spinal System, KyphonÖ HV-RÖ Bone Cement
Applicant
Medtronic
1800 Pyramid Place
Memphis, TN 38132 US
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Contact
Shweta Sharma
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PML
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More FDA Info for this Product Code
Date Received
05/22/2020
Decision Date
08/19/2020
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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