Zimmer Biomet Universal 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 Zimmer Biomet Universal Navigation System.

Pre-market Notification Details

Device IDK192133
510k NumberK192133
Device Name:Zimmer Biomet Universal Navigation System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Zimmer Biomet Spine, Inc. 10225 Westmoor Dr. Westminster,  CO  80021
ContactAlex Pawlowski
CorrespondentAlex Pawlowski
Zimmer Biomet Spine, Inc. 10225 Westmoor Dr. Westminster,  CO  80021
Product CodeOLO  
Subsequent Product CodeHAW
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeNKB
Subsequent Product CodeOSH
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-07
Decision Date2019-10-29
Summary:summary

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