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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 K202488
Device Name ZSFab Cervical Interbody System
ZSFab Inc.
705 Cambridge Street STE 1
Cambridge,  MA  02141
Applicant Contact Kai Xu
BackRoads Consulting Inc.
12520 Heath Road
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3080
Classification Product Code
Date Received08/31/2020
Decision Date 01/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No