RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

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

MAKO SURGICAL CORPORATION

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

Pre-market Notification Details

Device IDK133039
510k NumberK133039
Device Name:RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
ClassificationProsthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale,  FL  33317
ContactJonathan Reeves
CorrespondentJonathan Reeves
MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort 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 Received2013-09-26
Decision Date2013-12-10
Summary:summary

NIH GUDID Devices

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