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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 K263113
Device Name ZSAlign Cervical Interbody System
Applicant
ZSFab, Inc.
96 Clematis Ave.
Suite 2f
Waltham,  MA  02453
Applicant Contact David Ma
Correspondent
ATS Colorado Springs
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/04/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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