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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 K221858
Device Name ZSFab Lumbar Interbody System
Applicant
ZS Fab Inc.
96 Clematis Ave
Suite 2F
Waltham,  MA  02453
Applicant Contact Xuewei Ma
Correspondent
BackRoads Consulting Inc.
PO Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E Warden
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/27/2022
Decision Date 10/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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