TLC Unicompartmental Knee System

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Signature Orthopaedics Pty Ltd.

The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Tlc Unicompartmental Knee System.

Pre-market Notification Details

Device IDK212870
510k NumberK212870
Device Name:TLC Unicompartmental Knee System
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove,  AU 2066
ContactDeclan Brazil
CorrespondentDeclan Brazil
Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove,  AU 2066
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-09
Decision Date2022-06-16

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