MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III

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 Corporation Unicondylar Knee Implant System Iii.

Pre-market Notification Details

Device IDK082081
510k NumberK082081
Device Name:MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant MAKO SURGICAL CORP. 2555 DAVIE RD. Fort Lauderdale,  FL  33317
ContactWilliam F Tapia
CorrespondentWilliam F Tapia
MAKO SURGICAL CORP. 2555 DAVIE RD. Fort Lauderdale,  FL  33317
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-23
Decision Date2008-10-15
Summary:summary

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