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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 K183243
Device Name Velofix TLIF Cage
Applicant
U&i Corporation
20, Sandan-ro 76beon-gil(Rd)
Uijeongbu-si,  KR 11781
Applicant Contact Jee Ae Bang
Correspondent
U&i Corporation
20, Sandan-ro 76beon-gil(Rd)
Uijeongbu-si,  KR 11781
Correspondent Contact Jee-Ae Bang
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/21/2018
Decision Date 07/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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