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FDA 510(k) Application Details - K080588
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K080588
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
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
888.3080
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Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
03/03/2008
Decision Date
05/30/2008
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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