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FDA 510(k)

Balanced Knee Revision System Trabecular Tibial Cone Augments

K-Number: K182085 · 2018-10-31

ApplicantOrtho Development Corporation
Decision Date2018-10-31
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Balanced Knee Revision System Trabecular Tibial Cone Augments is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2018-10-31 under approval number K182085. 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 Revision System Trabecular Tibial Cone Augments?

Balanced Knee Revision System Trabecular Tibial Cone Augments is a medical device that received FDA 510(k) clearance on 2018-10-31. It is manufactured by Ortho Development Corporation. The 510(k) number is K182085.

When was Balanced Knee Revision System Trabecular Tibial Cone Augments approved by the FDA?

Balanced Knee Revision System Trabecular Tibial Cone Augments received FDA 510(k) clearance on 2018-10-31, under approval number K182085.

What company makes Balanced Knee Revision System Trabecular Tibial Cone Augments?

Balanced Knee Revision System Trabecular Tibial Cone Augments is manufactured by Ortho Development Corporation.

What is the FDA product code for Balanced Knee Revision System Trabecular Tibial Cone Augments?

The FDA product code for Balanced Knee Revision System Trabecular Tibial Cone Augments is JWH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING

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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