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FDA 510(k)

Rx Knee System

K-Number: K240683 · 2024-09-11

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2024-09-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Rx Knee System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2024-09-11 under approval number K240683. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rx Knee System?

Rx Knee System is a medical device that received FDA 510(k) clearance on 2024-09-11. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K240683.

When was Rx Knee System approved by the FDA?

Rx Knee System received FDA 510(k) clearance on 2024-09-11, under approval number K240683.

What company makes Rx Knee System?

Rx Knee System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Rx Knee System?

The FDA product code for Rx Knee System is JWH.

Other Devices by Signature Orthopaedics Pty, Ltd.

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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