FDA 510(k)

Consensus Knee System with TiNbN

K-Number: K241180 · 2025-01-14

Decision Date2025-01-14

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Consensus Knee System with TiNbN is a medical device manufactured by Shalby Advanced Technologies. It received FDA 510(k) clearance on 2025-01-14 under approval number K241180. 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 Consensus Knee System with TiNbN?

Consensus Knee System with TiNbN is a medical device that received FDA 510(k) clearance on 2025-01-14. It is manufactured by Shalby Advanced Technologies. The 510(k) number is K241180.

When was Consensus Knee System with TiNbN approved by the FDA?

Consensus Knee System with TiNbN received FDA 510(k) clearance on 2025-01-14, under approval number K241180.

What company makes Consensus Knee System with TiNbN?

Consensus Knee System with TiNbN is manufactured by Shalby Advanced Technologies.

What is the FDA product code for Consensus Knee System with TiNbN?

The FDA product code for Consensus Knee System with TiNbN is JWH.

Related Clinical Trials

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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

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