MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II

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 Mako Surgical Corp. Unicondylar Knee Implant System Ii.

Pre-market Notification Details

Device IDK080368
510k NumberK080368
Device Name:MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant MAKO SURGICAL CORP. 2555 DAVIE RD., SUITE 110 Ft. Lauderdale,  FL  33317
ContactWilliam F Tapia
CorrespondentWilliam F Tapia
MAKO SURGICAL CORP. 2555 DAVIE RD., SUITE 110 Ft. Lauderdale,  FL  33317
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-12
Decision Date2008-06-20
Summary:summary

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