EXULT Knee Replacement System
FDA 510(k) clearance K250889 · decided 2025-04-17
Clearance details
- K-number
- K250889
- Device name
- EXULT Knee Replacement System
- Applicant
- Corentec Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-25
- Decision date
- 2025-04-17
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Chungchongnam-Do, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.