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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 Integrated Fixation, Cervical
510(k) Number K252982
Device Name CONDUIT™ ZERO-P™ VA Secured Spacer System
Applicant
Avalign Technologies, Inc.
8727 Clinton Park Dr.
Fort Wayne,  IN  46825
Applicant Contact Jennifer Staunton
Correspondent
Avalign Technologies, Inc.
8727 Clinton Park Dr.
Fort Wayne,  IN  46825
Correspondent Contact Jennifer Staunton
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received09/17/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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