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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, Lumbar
510(k) Number K252610
Device Name ZSFab Lumbar Interbody System
Applicant
Zsfab, Inc.
96 Clematis Ave.
2f
Waltham,  MA  02453
Applicant Contact Sijin Ren
Correspondent
Applied Technical Services (Empirical Technologies)
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/18/2025
Decision Date 11/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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