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FDA 510(k) Application Details - K051000
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K051000
Device Name
Spinal Vertebral Body Replacement Device
Applicant
SPINAL CONCEPTS, INC.
5301 RIATA PARK CT., BLDG. F
AUSTIN, TX 78727 US
Other 510(k) Applications for this Company
Contact
NOAH BARTSCH
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
04/20/2005
Decision Date
05/19/2005
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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