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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K182848
Device Name ROSA ONE Spine application
Applicant
Medtech S.A.
ZAC Eureka - 900 Rue du Mas de Verchant
Montpellier,  FR 34000
Applicant Contact Serge Tabet
Correspondent
Medtech S.A.
ZAC Eureka - 900 Rue du Mas de Verchant
Montpellier,  FR 34000
Correspondent Contact Serge Tabet
Regulation Number882.4560
Classification Product Code
OLO  
Date Received10/09/2018
Decision Date 03/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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