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FDA 510(k) Application Details - K230689
Device Classification Name
More FDA Info for this Device
510(K) Number
K230689
Device Name
T-FIXÖ 3DSI Joint Fusion System
Applicant
Cutting Edge Spine, LLC
6012 Waxhaw Hwy
Mineral Springs, NC 28108 US
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Contact
Kyle Kuntz
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OUR
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More FDA Info for this Product Code
Date Received
03/13/2023
Decision Date
04/05/2023
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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