UNITED U2 TOTAL KNEE SYSTEM
FDA 510(k) clearance K082424 · decided 2008-12-16
Clearance details
- K-number
- K082424
- Device name
- UNITED U2 TOTAL KNEE SYSTEM
- Applicant
- United Orthopedic Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-22
- Decision date
- 2008-12-16
- Days to decision
- 116 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
| Record | Firm | Date |
|---|---|---|
| Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R recall (Z-2883-2026) | United Orthopedic Corp. | 2026-08-05 |