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FDA 510(k) Application Details - K113781
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K113781
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
PANTHEON SPINAL
9442 CAPITAL OF TEXAS
HWY NORTH - SUITE 900
AUSTIN, TX 78759 US
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Contact
SCOTT SPANN
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
12/22/2011
Decision Date
04/26/2013
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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