K243634
- 510(k) number
- K243634
- Device name
- Maxx Libertas Bipolar Hip Head (Bipolar Hip)
- Applicant
- Maxx Orthopedics, Inc. PA · US
- Product code
- KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Ceme
- Decision date
- 2025-08-25
- Date received
- 2024-11-25
- 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: K243634.pdf
Official FDA record: K243634
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.