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FDA 510(k) Application Details - K080690
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K080690
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
THEKEN SPINE LLC
1800 TRIPLETT BLVD.
AKRON, OH 44306 US
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Contact
DALE DAVISON
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
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More FDA Info for this Product Code
Date Received
03/11/2008
Decision Date
04/25/2008
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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