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FDA 510(k) Application Details - K110927
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K110927
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
MEDACTA INTERNATIONAL
4725 Calle Quetzal, Unit B
Camarillo, CA 93012 US
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Contact
ADAM GROSS
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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
03/28/2011
Decision Date
06/13/2011
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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