Virage Navigation System

Orthopedic Stereotaxic Instrument

Zimmer Biomet Spine, Inc.

The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for Virage Navigation System.

Pre-market Notification Details

Device IDK212023
510k NumberK212023
Device Name:Virage Navigation System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster,  CO  80021
ContactDavid Pollard
CorrespondentDavid Pollard
Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster,  CO  80021
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-29
Decision Date2021-08-27

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