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FDA 510(k) Application Details - K083167
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
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510(K) Number
K083167
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
SPINAL DEVICES, LLC
13540 GUILD AVE
APPLE VALLEY, MN 55124 US
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Contact
RICHARD JANSEN
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Regulation Number
888.3080
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Classification Product Code
ODP
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More FDA Info for this Product Code
Date Received
10/27/2008
Decision Date
01/13/2009
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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