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FDA 510(k) Application Details - K100945
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
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510(K) Number
K100945
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
ADVANCED MEDICAL TECHNOLOGIES AG
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
04/06/2010
Decision Date
02/09/2011
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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