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FDA 510(k) Application Details - K060665
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K060665
Device Name
Spinal Vertebral Body Replacement Device
Applicant
GLOBUS MEDICAL INC.
303 SCHELL LN.
PHOENIXVILLE, PA 19460 US
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Contact
KELLY J BAKER
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
03/14/2006
Decision Date
05/10/2006
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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