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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 K221325
Device Name CONDUIT Lateral Switch Plate
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact LiJuan He
Correspondent
Depuy Spine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact LiJuan He
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OVD  
Date Received05/06/2022
Decision Date 08/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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