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FDA 510(k) Application Details - K020048
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K020048
Device Name
Spinal Vertebral Body Replacement Device
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact
LYNN M RODARTI
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
01/07/2002
Decision Date
02/06/2002
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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