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FDA 510(k) Application Details - K142112
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K142112
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
4WEB, INC.
11821 BRAMBLE COVE DRIVE
FT.MYERS, FL 33905 US
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Contact
RICH JANSEN
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
08/04/2014
Decision Date
09/23/2014
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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