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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K250375
Device Name Allure Hip Stem and Intramedullary Plugs
Applicant
Waldemar Link GmbH & Co. KG
Barkhausenweg 10
Hamburg,  DE 22339
Applicant Contact Pia Müller
Correspondent
LinkBio Corp.
69 King St.
Dover,  NJ  07801
Correspondent Contact Terry Powell
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWY   LPH   LZO   OQG  
Date Received02/10/2025
Decision Date 11/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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