Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Allure Hip Stem and Intramedullary Plugs

K-Number: K250375 · 2025-11-05

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2025-11-05
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Allure Hip Stem and Intramedullary Plugs is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2025-11-05 under approval number K250375. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Allure Hip Stem and Intramedullary Plugs?

Allure Hip Stem and Intramedullary Plugs is a medical device that received FDA 510(k) clearance on 2025-11-05. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K250375.

When was Allure Hip Stem and Intramedullary Plugs approved by the FDA?

Allure Hip Stem and Intramedullary Plugs received FDA 510(k) clearance on 2025-11-05, under approval number K250375.

What company makes Allure Hip Stem and Intramedullary Plugs?

Allure Hip Stem and Intramedullary Plugs is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for Allure Hip Stem and Intramedullary Plugs?

The FDA product code for Allure Hip Stem and Intramedullary Plugs is MEH.

Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

View all 29 devices →

Related Devices (Code: MEH)

K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc. K160011H-Max S stemLima Corporate S.P.A. K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd. K160907DePuy Actis DuoFix Hip ProsthesisDepuy(Ireland) K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerSignature Orthopaedics Pty, Ltd. K153772Corin TriFit TS HipCorin U.S.A. Limited

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.

↑