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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 K190067
Device Name Velofix Interbody Fusion System
Applicant
U&I Corporation
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Applicant Contact Jee-Ae Bang
Correspondent
U&I Corporation
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Correspondent Contact Jee-Ae Bang
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received01/15/2019
Decision Date 02/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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