RESTORIS Multicompartmental Knee System

Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer

MAKO SURGICAL CORP.

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

Pre-market Notification Details

Device IDK150307
510k NumberK150307
Device Name:RESTORIS Multicompartmental Knee System
ClassificationProsthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MAKO SURGICAL CORP. 2555 DAVIE RD. Ft. Lauderdale,  FL  33317
ContactJonathan Reeves
CorrespondentJonathan Reeves
MAKO SURGICAL CORP. 2555 DAVIE RD. Ft. Lauderdale,  FL  33317
Product CodeNPJ  
Subsequent Product CodeHRY
Subsequent Product CodeHSX
Subsequent Product CodeKRR
Subsequent Product CodeOIY
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-09
Decision Date2015-03-10
Summary:summary

NIH GUDID Devices

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