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FDA 510(k) Application Details - K071372
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K071372
Device Name
Spinal Vertebral Body Replacement Device
Applicant
RSB SPINE LLC.
8202 SHERMAN ROAD
CHESTERLAND, OH 44026 US
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Contact
KAREN WARDEN
Other 510(k) Applications for this Contact
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
05/16/2007
Decision Date
06/11/2007
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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