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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 Integrated Fixation, Lumbar
510(k) Number K191263
Device Name Idys ALIF TiVac
Applicant
Clariance, Sas
18, Rue Robespierre
Beaurains,  FR 62217
Applicant Contact Fadwa Bahr
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3080
Classification Product Code
OVD  
Date Received05/10/2019
Decision Date 06/06/2019
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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