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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 K192173
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 Received08/12/2019
Decision Date 10/29/2019
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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