UKNEE TOTAL KNEE SYSTEM
FDA 510(k) clearance K021657 · decided 2002-08-12
Clearance details
- K-number
- K021657
- Device name
- UKNEE TOTAL KNEE SYSTEM
- Applicant
- United Orthopedic Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-20
- Decision date
- 2002-08-12
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hsinchu, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.