KneeAlign 2 System

Orthopedic Stereotaxic Instrument

OrthAlign, Inc.

The following data is part of a premarket notification filed by Orthalign, Inc. with the FDA for Kneealign 2 System.

Pre-market Notification Details

Device IDK163379
510k NumberK163379
Device Name:KneeAlign 2 System
ClassificationOrthopedic Stereotaxic Instrument
Applicant OrthAlign, Inc. 120 Columbia, Suite 500 Aliso Viejo,  CA  92656
ContactDavid Vancelette
CorrespondentDavid Vancelette
OrthAlign, Inc. 120 Columbia, Suite 500 Aliso Viejo,  CA  92656
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-01
Decision Date2017-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810832031123 K163379 000

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