KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT

Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Kneetec Pfj&hls Kneetec Patellar Component.

Pre-market Notification Details

Device IDK111970
510k NumberK111970
Device Name:KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
ClassificationProsthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Applicant TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex,  FR 38334
ContactStephanie Bernard
CorrespondentStephanie Bernard
TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex,  FR 38334
Product CodeKRR  
CFR Regulation Number888.3540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-11
Decision Date2012-02-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03700386937712 K111970 000

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