K242401
- 510(k) number
- K242401
- Device name
- EXULT Knee Replacement System
- Applicant
- Corentec Co., Ltd. KR
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2024-09-12
- Date received
- 2024-08-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K242401.pdf
Official FDA record: K242401
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.