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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 K223251
Device Name Hexanium PLIF
Applicant
SpineVision, S.A.S.
10 Rue de la Renaissance
Antony,  FR 92160
Applicant Contact Quang Tran
Correspondent
Lince Consulting, LLC
111 Deerwood Road, Suite 200
San Ramon,  CA  94583
Correspondent Contact Nancy Lince
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/21/2022
Decision Date 12/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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