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510(k) K250375

Allure Hip Stem and Intramedullary Plugs by Waldemar Link GmbH & Co. KG — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2025
Date Received
February 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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