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FDA 510(k) Application Details - K152604
Device Classification Name
More FDA Info for this Device
510(K) Number
K152604
Device Name
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
Applicant
Medtronic Sofamor Danek USA, Incorporated
1800 Pyramid Place
Memphis, TN 38132 US
Other 510(k) Applications for this Company
Contact
Pamela Edwards
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PML
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/11/2015
Decision Date
01/06/2016
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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