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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 K222510
Device Name Blueprint Mixed Reality system
Applicant
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Applicant Contact Moyees Kamara
Correspondent
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Correspondent Contact Moyees Kamara
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received08/19/2022
Decision Date 01/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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