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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K240085
Device Name zLOCK Lumbar Facet Fixation System
Applicant
Zygofix , Ltd.
17 Tchelet St.
Misgav,  IL 2017900
Applicant Contact Ofer Levy
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Classification Product Code
MRW  
Date Received01/11/2024
Decision Date 04/18/2024
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT04229316
NCT05266521
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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