K240528
- 510(k) number
- K240528
- Device name
- b-ONE® Total Hip System
- Applicant
- B-One Ortho, Corp. NJ · US
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2024-11-15
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240528.pdf
Official FDA record: K240528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.