Vital Navigation System

Orthopedic Stereotaxic Instrument

ZimVie (Zimmer Biomet Spine, Inc.)

The following data is part of a premarket notification filed by Zimvie (zimmer Biomet Spine, Inc.) with the FDA for Vital Navigation System.

Pre-market Notification Details

Device IDK213720
510k NumberK213720
Device Name:Vital Navigation System
ClassificationOrthopedic Stereotaxic Instrument
Applicant ZimVie (Zimmer Biomet Spine, Inc.) 10225 Westmoor Drive Westminster,  CO  80021
ContactHanna Aucoin
CorrespondentHanna Aucoin
ZimVie (Zimmer Biomet Spine, Inc.) 10225 Westmoor Drive Westminster,  CO  80021
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-24
Decision Date2022-01-07

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