K232371
- 510(k) number
- K232371
- Device name
- Actinia® hip stems
- Applicant
- Implantcast GmbH DE
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2023-10-19
- Date received
- 2023-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232371.pdf
Official FDA record: K232371
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.