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FDA 510(k) Application Details - K063399
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K063399
Device Name
Spinal Vertebral Body Replacement Device
Applicant
K2M, INC.
751 MILLER DR.,SE
LEESBURG, VA 20175 US
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Contact
RICH WOODS
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
11/09/2006
Decision Date
02/23/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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