Spine Guidance Software, Stryker Q Guidance System

Orthopedic Stereotaxic Instrument

Stryker Leibinger GmbH & Co. KG

The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Spine Guidance Software, Stryker Q Guidance System.

Pre-market Notification Details

Device IDK220593
510k NumberK220593
Device Name:Spine Guidance Software, Stryker Q Guidance System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 Freiburg,  DE D-79111
ContactAndrea Wallen-Gerding
CorrespondentAndrea Wallen-Gerding
Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 Freiburg,  DE D-79111
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-01
Decision Date2022-05-27

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