BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
FDA 510(k) clearance K060569 · decided 2006-07-06
Clearance details
- K-number
- K060569
- Device name
- BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
- Applicant
- Ortho Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-03
- Decision date
- 2006-07-06
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE compone recall (Z-2257-2014) | Ortho Development Corporation | 2014-08-17 |