K243043
- 510(k) number
- K243043
- Device name
- Origin Cemented Hip Stem
- Applicant
- Signature Orthopaedics Pty, Ltd. AU
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2025-05-02
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243043.pdf
Official FDA record: K243043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.