RESTORIS MULTICOMPARTMENTAL KNEE (MCK) 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 (mck) System.

Pre-market Notification Details

Device IDK090763
510k NumberK090763
Device Name:RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
ClassificationProsthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale,  FL  33317
ContactWilliam F Tapia
CorrespondentWilliam F Tapia
MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale,  FL  33317
Product CodeNPJ  
Subsequent Product CodeHRY
Subsequent Product CodeHSX
Subsequent Product CodeKRR
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-23
Decision Date2009-06-17
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.