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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 K243670
Device Name Idys® LIF
Applicant
Clariance
18, Rue Robespierre
Beaurains,  FR 62217
Applicant Contact Quang Tran
Correspondent
Clariance
18, Rue Robespierre
Beaurains,  FR 62217
Correspondent Contact Quang Tran
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/27/2024
Decision Date 12/31/2024
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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