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FDA 510(k)

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer

K-Number: K183017 · 2019-07-25

ApplicantOsteoremedies, LLC
Decision Date2019-07-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer is a medical device manufactured by Osteoremedies, LLC. It received FDA 510(k) clearance on 2019-07-25 under approval number K183017. 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 Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer?

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer is a medical device that received FDA 510(k) clearance on 2019-07-25. It is manufactured by Osteoremedies, LLC. The 510(k) number is K183017.

When was Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer approved by the FDA?

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer received FDA 510(k) clearance on 2019-07-25, under approval number K183017.

What company makes Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer?

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer is manufactured by Osteoremedies, LLC.

What is the FDA product code for Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer?

The FDA product code for Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer is JWH.

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Other Devices by Osteoremedies, LLC

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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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