ARVIS Surgical Navigation System

Orthopedic Stereotaxic Instrument

Insight Medical Systems Inc.

The following data is part of a premarket notification filed by Insight Medical Systems Inc. with the FDA for Arvis Surgical Navigation System.

Pre-market Notification Details

Device IDK203115
510k NumberK203115
Device Name:ARVIS Surgical Navigation System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Insight Medical Systems Inc. 25892 La Cuesta Avenue Laguna Hills,  CA  92653
ContactNicholas R. Van Der Walt
CorrespondentBob Duffy
Bob Duffy Associates, Inc. 16405 Summer Sage Rd. Poway,  CA  92064
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-16
Decision Date2021-07-14

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