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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 K250186
Device Name GoLIF! Lumbar Interbody Fusion System
Applicant
GetSet Surgical, SA
Route de la Corniche 4
Epalinges
Vaud,  CH 1066
Applicant Contact Jowita Sokalska
Correspondent
MRC Global
9085 East Mineral Circle
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/22/2025
Decision Date 03/21/2025
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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