ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
FDA 510(k) clearance K031201 · decided 2003-07-15
Clearance details
- K-number
- K031201
- Device name
- ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
- Applicant
- Ortho Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-16
- Decision date
- 2003-07-15
- Days to decision
- 90 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 |
|---|---|---|
| 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System. recall (Z-1228-2010) | Ortho Development Corporation | 2010-04-05 |
| 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The de recall (Z-1229-2010) | Ortho Development Corporation | 2010-04-05 |