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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 K232292
Device Name Peridot-EX Expandable Intervertebral Body Fusion System
Applicant
Gbs Commonwealth Co., Ltd.
C-309. Woolim Lion'S Valley, 168, Gasan Digital 1-Ro
Geumcheon-Gu,  KR 08507
Applicant Contact Jimmy Kim
Correspondent
Gbs Commonwealth Co., Ltd.
C-309. Woolim Lion'S Valley, 168, Gasan Digital 1-Ro
Geumcheon-Gu,  KR 08507
Correspondent Contact Jimmy Kim
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/01/2023
Decision Date 11/07/2023
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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