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FDA 510(k) Application Details - K191565
Device Classification Name
More FDA Info for this Device
510(K) Number
K191565
Device Name
Endoskeleton TCS Interbody Fusion Device
Applicant
Titan Spine, Inc
6140 W. Executive Dr., Suite A
Mequon, WI 53092 US
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Contact
Kelly McDonnell
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Regulation Number
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Classification Product Code
OVE
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Date Received
06/13/2019
Decision Date
08/06/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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