FDA 510(k) K240062, ARVIS® Shoulder, by Insight Medical Systems, Inc.
FDA 510(k) K240062, ARVIS® Shoulder, by Insight Medical Systems, Inc.
Device Classification Name: Orthopedic Stereotaxic Instrument
510(k) Number: K240062
Device Name: ARVIS® Shoulder
Applicant: Insight Medical Systems, Inc.
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 01/09/2024
Decision Date: 04/29/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
510k Review Panel: Orthopedic
Total number of pages: 2,693
Fully redacted pages: 2,327
Content pages: 366
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