K234025
- 510(k) number
- K234025
- Device name
- 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics NJ · US
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2024-04-24
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K234025.pdf
Official FDA record: K234025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.