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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 K260549
Device Name ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
Applicant
Zsfab, Inc.
96 Clematis Ave.
Suite 2f
Waltham,  MA  02453
Applicant Contact Yuanqiao Wu
Correspondent
Applied Technical Services (Empirical Technologies)
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received02/18/2026
Decision Date 04/24/2026
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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