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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 K242734
Device Name ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System
Applicant
Zsfab
96 Clematis Ave.
Suite 2f
Waltham,  MA  02453
Applicant Contact Yuanqiao Wu
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received09/10/2024
Decision Date 11/07/2024
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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