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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K202505
Device Name GetSet Surgical GoPLF! Posterior Lateral Fusion System
Applicant
Getset Surgical, SA
Route De La Corniche 4
Epalinges,  CH 1066
Applicant Contact Ole Stoklund
Correspondent
Kapstone Medical, LLC
520 Elliot St.
Charlotte,  NC  28202
Correspondent Contact Carolyn Guthrie
Regulation Number888.3070
Classification Product Code
NKB  
Date Received08/31/2020
Decision Date 01/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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