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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 K210728
Device Name CONDUIT Instruments
Applicant
Medos International, SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Christine Cahillane
Correspondent
DePuy Spine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Christine Cahillane
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received03/11/2021
Decision Date 05/06/2021
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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