K240391
- 510(k) number
- K240391
- Device name
- MUTARS® femoral stem cemented 160 mm and 200 mm
- Applicant
- Implantcast GmbH DE
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2024-10-24
- Date received
- 2024-02-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K240391.pdf
Official FDA record: K240391
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.