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FDA 510(k)

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement

K-Number: K172906 · 2018-08-29

ApplicantOsteoremedies, LLC
Decision Date2018-08-29
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement is a medical device manufactured by Osteoremedies, LLC. It received FDA 510(k) clearance on 2018-08-29 under approval number K172906. 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 PLUS Hip Spacer, UNITE PLUS Bone Cement?

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by Osteoremedies, LLC. The 510(k) number is K172906.

When was REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement approved by the FDA?

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement received FDA 510(k) clearance on 2018-08-29, under approval number K172906.

What company makes REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement?

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement is manufactured by Osteoremedies, LLC.

What is the FDA product code for REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement?

The FDA product code for REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement is KWL.

Other Devices by Osteoremedies, LLC

K173967Remedy Acetabular Cup 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)

K173967Remedy Acetabular CupOsteoremedies, 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.

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