EXULT Femoral component trial - Left, EXULT Femoral component trial - Right
FDA 510(k) clearance K201851 · decided 2020-07-30
Clearance details
- K-number
- K201851
- Device name
- EXULT Femoral component trial - Left, EXULT Femoral component trial - Right
- Applicant
- Corentec Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-06
- Decision date
- 2020-07-30
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cheonan, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.