Restoris Multi-Compartmental Knee System

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Mako Surgical Corp.

The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Restoris Multi-compartmental Knee System.

Pre-market Notification Details

Device IDK220930
510k NumberK220930
Device Name:Restoris Multi-Compartmental Knee System
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Mako Surgical Corp. 3365 Enterprise Ave Weston,  FL  33331
ContactEmily DiMambro
CorrespondentEmily DiMambro
Mako Surgical Corp. 3365 Enterprise Ave Weston,  FL  33331
Product CodeHSX  
Subsequent Product CodeHRY
Subsequent Product CodeKRR
Subsequent Product CodeNPJ
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-06-02

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