K250889
- 510(k) number
- K250889
- Device name
- EXULT Knee Replacement System
- Applicant
- Corentec Co., Ltd. KR
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2025-04-17
- Date received
- 2025-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250889.pdf
Official FDA record: K250889
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.