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FDA 510(k) Application Details - K060416
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K060416
Device Name
Spinal Vertebral Body Replacement Device
Applicant
ULRICH GMBH & CO. KG
2519 MCMULLEN BOOTH ROAD
SUITE 510-295
CLEARWATER, FL 33759 US
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Contact
IAN P GORDON
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
MQP
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More FDA Info for this Product Code
Date Received
02/17/2006
Decision Date
12/26/2006
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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