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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 K240062
Device Name ARVIS® Shoulder
Applicant
Insight Medical Systems, Inc.
9801 Metric Blvd
Suite 200
Austin,  TX  78758
Applicant Contact Matthew Ryan
Correspondent
Stefanie Michele Auf der Mauer Asmuss (sole trader)
22 Monfield
Rochestown,  IE T12C65D
Correspondent Contact Stefanie Auf der Mauer
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
LLZ   QIH  
Date Received01/09/2024
Decision Date 04/29/2024
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
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