K250375
- 510(k) number
- K250375
- Device name
- Allure Hip Stem and Intramedullary Plugs
- Applicant
- Waldemar Link GmbH & Co. KG DE
- Product code
- MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal
- Decision date
- 2025-11-05
- Date received
- 2025-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250375.pdf
Official FDA record: K250375
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.