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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, Cervical
510(k) Number K213755
Device Name Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT 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
ODP  
Subsequent Product Code
MAX  
Date Received11/30/2021
Decision Date 02/17/2023
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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