K253357
- 510(k) number
- K253357
- Device name
- b-ONE® Bipolar Head
- Applicant
- B-One Ortho, Corp. NJ · US
- Product code
- KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Ceme
- Decision date
- 2026-04-13
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253357.pdf
Official FDA record: K253357
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.