RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

PLUS ORTHOPEDICS

The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Rt-plus Solution & Rt-plus Modular Solution Knee.

Pre-market Notification Details

Device IDK023667
510k NumberK023667
Device Name:RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock,  TX  78681 -2700
ContactJ.d. Webb
CorrespondentJ.d. Webb
PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock,  TX  78681 -2700
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-31
Decision Date2002-12-24
Summary:summary

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