K243927
- 510(k) number
- K243927
- Device name
- MobileLink Acetabular Cup System - inhouse coatings
- Applicant
- Waldemar Link GmbH & Co. KG DE
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2025-05-16
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243927.pdf
Official FDA record: K243927
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.