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FDA 510(k) Application Details - K062133
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K062133
Device Name
Spinal Vertebral Body Replacement Device
Applicant
MEDTRONIC SPINAL AND BIOLOGICS DIV
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
Other 510(k) Applications for this Company
Contact
LEE GRANT
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
MQP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/26/2006
Decision Date
09/26/2006
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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