K261576
- 510(k) number
- K261576
- Device name
- Icona Hip Stem
- Applicant
- Corin, Ltd. GB
- Product code
- MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal
- Decision date
- 2026-08-10
- Date received
- 2026-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K261576.pdf
Official FDA record: K261576
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.