FDA 510(k)

Remedy Acetabular Cup

K-Number: K173967 · 2018-02-22

Decision Date2018-02-22

Product CodeKWL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Remedy Acetabular Cup is a medical device manufactured by Osteoremedies, LLC. It received FDA 510(k) clearance on 2018-02-22 under approval number K173967. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Remedy Acetabular Cup?

Remedy Acetabular Cup is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by Osteoremedies, LLC. The 510(k) number is K173967.

When was Remedy Acetabular Cup approved by the FDA?

Remedy Acetabular Cup received FDA 510(k) clearance on 2018-02-22, under approval number K173967.

What company makes Remedy Acetabular Cup?

Remedy Acetabular Cup is manufactured by Osteoremedies, LLC.

What is the FDA product code for Remedy Acetabular Cup?

The FDA product code for Remedy Acetabular Cup is KWL.

Other Devices by Osteoremedies, LLC

K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement K191981REMEDY Acetabular Cup K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer K192995OsteoRemedies Hip Spacer System K231556SPECTRUM® GV Bone Cement K223650REMEDY Stemmed Knee Spacer

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Related Devices (Code: KWL)

K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC K191981REMEDY Acetabular CupOsteoremedies, LLC K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC

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.