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FDA 510(k) Application Details - K082466
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K082466
Device Name
Spinal Vertebral Body Replacement Device
Applicant
VERTEBRATION,INC
310 TERRACE AVENUE, SUITE 201
CINCINNATI, OH 45220 US
Other 510(k) Applications for this Company
Contact
BARBARA FANT
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
08/27/2008
Decision Date
01/09/2009
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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