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FDA 510(k) Application Details - K113527
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K113527
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
INTERVENTIONAL SPINE, INC.
13700 ALTON PKWY., SUITE 160
IRVINE, CA 92618 US
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Contact
JANE METCALF
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
11/30/2011
Decision Date
01/20/2012
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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