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FDA 510(k) Application Details - K024364
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K024364
Device Name
Spinal Vertebral Body Replacement Device
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI, PA 19301 US
Other 510(k) Applications for this Company
Contact
JONATHAN GILBERT
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
12/31/2002
Decision Date
03/17/2003
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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