IASSIST Knee System

Orthopedic Stereotaxic Instrument

Orthosoft Inc. (d/b/a Zimmer CAS)

The following data is part of a premarket notification filed by Orthosoft Inc. (d/b/a Zimmer Cas) with the FDA for Iassist Knee System.

Pre-market Notification Details

Device IDK192080
501k NumberK192080
Device Name:IASSIST Knee System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal,  CA H3c 2n6
ContactEduardo Mendoza
CorrespondentEduardo Mendoza
Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal,  CA H3c 2n6
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-02
Decision Date2019-11-05

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