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FDA 510(k) Application Details - K081548
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K081548
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SCIENT'X USA, INC.
1015 MAITLAND CENTER COMMONS
SUITE 106A
MAITLAND, FL 32751 US
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Contact
JOHN SANDERS
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2008
Decision Date
01/29/2009
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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