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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 Rd.
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
Predetermined Change
Control Plan Authorized		 No
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