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FDA 510(k) Application Details - K071726
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K071726
Device Name
Spinal Vertebral Body Replacement Device
Applicant
SEASPINE, INC.
2302 LA MIRADA DR.
VISTA, CA 92081-7862 US
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Contact
ETHEL BERNAL
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
MQP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/25/2007
Decision Date
10/23/2007
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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