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FDA 510(k) Application Details - K123652
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
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510(K) Number
K123652
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
SPINEOLOGY, INC.
7800 3RD ST N., SUITE 600
ST. PAUL, MN 55128 US
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Contact
BRYAN BECKER
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
11/27/2012
Decision Date
03/22/2013
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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