510(k) K250375
K250375 is an FDA 510(k) premarket notification submitted by Waldemar Link GmbH & Co. KG for the device "Allure Hip Stem and Intramedullary Plugs". The FDA issued a decision of Substantially Equivalent on November 5, 2025. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Waldemar Link GmbH & Co. KG has at least 10 other 510(k) clearances on record.
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