Arthrex IBalance BiCompartmental Arthroplasty System

Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

Arthrex, Inc.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ibalance Bicompartmental Arthroplasty System.

Pre-market Notification Details

Device IDK160461
510k NumberK160461
Device Name:Arthrex IBalance BiCompartmental Arthroplasty System
ClassificationProsthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Applicant Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactCourtney Smith
CorrespondentCourtney Smith
Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeKRR  
CFR Regulation Number888.3540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-19
Decision Date2016-04-12
Summary:summary

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