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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K243673
Device Name Xenco Medical CancelleX Cervical Interbody System
Applicant
Xenco Medical, LLC
9930 Mesa Rim Rd.
San Diego,  CA  92121
Applicant Contact Jason Haider
Correspondent
Watershed Idea Foundry, Inc. (Dba Spitrex 3D)
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact Jeffrey Brittan
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/27/2024
Decision Date 01/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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