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FDA 510(k) Application Details - K071274
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K071274
Device Name
Spinal Vertebral Body Replacement Device
Applicant
GOLD STANDARD ORTHOPEDICS LLC
1226 ROWAN ST.
LOUISVILLE, KY 40203 US
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Contact
DAVID BAUGHMAN
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
MQP
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More FDA Info for this Product Code
Date Received
05/07/2007
Decision Date
08/24/2007
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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