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FDA 510(k) Application Details - K080537
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K080537
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
KISCOMEDICA S.A.
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
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Contact
J.D. WEBB
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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
02/27/2008
Decision Date
06/30/2008
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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