K241241
- 510(k) number
- K241241
- Device name
- Z1 Cemented Hip System
- Applicant
- Orchard Medical Development, LLC IL · US
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2024-08-27
- Date received
- 2024-05-03
- 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: K241241.pdf
Official FDA record: K241241
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.