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FDA 510(k) Application Details - K073669
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K073669
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
CHOICE SPINE, LP
8202 SHERMAN ROAD
CHESTERLAND, OH 44026-2141 US
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Contact
KAREN E WARDEN
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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
12/26/2007
Decision Date
02/13/2008
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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