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FDA 510(k) Application Details - K060916
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K060916
Device Name
Spinal Vertebral Body Replacement Device
Applicant
SPINAL EDGE, LLC
25125 DETROIT ROAD
WESTLAKE, OH 44145 US
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Contact
CHRISTINA VACCA
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
04/04/2006
Decision Date
06/08/2006
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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