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FDA 510(k)

TLC Unicompartmental Knee System

K-Number: K212870 · 2022-06-16

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2022-06-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TLC Unicompartmental Knee System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2022-06-16 under approval number K212870. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TLC Unicompartmental Knee System?

TLC Unicompartmental Knee System is a medical device that received FDA 510(k) clearance on 2022-06-16. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K212870.

When was TLC Unicompartmental Knee System approved by the FDA?

TLC Unicompartmental Knee System received FDA 510(k) clearance on 2022-06-16, under approval number K212870.

What company makes TLC Unicompartmental Knee System?

TLC Unicompartmental Knee System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for TLC Unicompartmental Knee System?

The FDA product code for TLC Unicompartmental Knee System is HSX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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