NUFFIELD TOTAL KNEE

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

TURNKEY INTERGRATION USA, INC.

The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Nuffield Total Knee.

Pre-market Notification Details

Device IDK931960
510k NumberK931960
Device Name:NUFFIELD TOTAL KNEE
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis,  IN  46250
ContactDouglas Stuart
CorrespondentDouglas Stuart
TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis,  IN  46250
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-21
Decision Date1994-10-07

NIH GUDID Devices

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