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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 K192168
Device Name Idys ALIF ZP 3DTi
Applicant
CLARIANCE, SAS
18 rue Robespierre
Beaurains,  FR 62217
Applicant Contact Fadwa Bahr
Correspondent
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3080
Classification Product Code
OVD  
Date Received08/09/2019
Decision Date 11/04/2019
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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