K243839
- 510(k) number
- K243839
- Device name
- Alteon® HA Femoral Stems
- Applicant
- Exactech, Inc. FL · US
- Product code
- MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal
- Decision date
- 2025-03-10
- Date received
- 2024-12-13
- 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: K243839.pdf
Official FDA record: K243839
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.