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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 K181048
Device Name Neo Cage System TM
Applicant
Neo Medical S.A.
Route de Lausanne 157 A
Villette,  CH 1096
Applicant Contact Jonas Larsson
Correspondent
confinis USA
Route de Lausanne 157A
Villette (Lavaux),  CH 1096
Correspondent Contact Jonas Larsson
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/19/2018
Decision Date 01/29/2019
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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