K233476
- 510(k) number
- K233476
- Device name
- Z1 Hip System
- Applicant
- Orchard Medical Development IL · US
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2024-02-08
- Date received
- 2023-10-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233476.pdf
Official FDA record: K233476
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.