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FDA 510(k)

Balanced Knee® System TriMax PS Plus Tibial Insert

K-Number: K233093 · 2023-10-25

ApplicantOrtho Development Corporation
Decision Date2023-10-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Balanced Knee® System TriMax PS Plus Tibial Insert is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2023-10-25 under approval number K233093. 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 Balanced Knee® System TriMax PS Plus Tibial Insert?

Balanced Knee® System TriMax PS Plus Tibial Insert is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Ortho Development Corporation. The 510(k) number is K233093.

When was Balanced Knee® System TriMax PS Plus Tibial Insert approved by the FDA?

Balanced Knee® System TriMax PS Plus Tibial Insert received FDA 510(k) clearance on 2023-10-25, under approval number K233093.

What company makes Balanced Knee® System TriMax PS Plus Tibial Insert?

Balanced Knee® System TriMax PS Plus Tibial Insert is manufactured by Ortho Development Corporation.

What is the FDA product code for Balanced Knee® System TriMax PS Plus Tibial Insert?

The FDA product code for Balanced Knee® System TriMax PS Plus Tibial Insert is JWH.

Related Clinical Trials

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Other Devices by Ortho Development Corporation

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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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