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FDA 510(k) Application Details - K063205
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K063205
Device Name
Spinal Vertebral Body Replacement Device
Applicant
ATLAS SPINE LLC
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
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Contact
FLOYD G LARSON
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
MQP
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More FDA Info for this Product Code
Date Received
10/23/2006
Decision Date
02/26/2007
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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