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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 K221687
Device Name Pegasus-X Expandable PLIF System
Applicant
GS Medical Co. Ltd.
90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu
Cheongju-si,  KR 28161
Applicant Contact Sam Camp
Correspondent
RQMIS Inc.
110 Haverhill Road, Suite 524
Amesbury,  MA  01913
Correspondent Contact Barry E. Sands
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/10/2022
Decision Date 07/27/2022
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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