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FDA 510(k) Application Details - K040168
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K040168
Device Name
Spinal Vertebral Body Replacement Device
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact
WENDY SPIELBERGER
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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
01/26/2004
Decision Date
04/08/2004
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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