ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
FDA 510(k) clearance K994370 · decided 2000-03-24
Clearance details
- K-number
- K994370
- Device name
- ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
- Applicant
- Ortho Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-27
- Decision date
- 2000-03-24
- Days to decision
- 88 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 |
|---|---|---|
| Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resur recall (Z-2254-2014) | Ortho Development Corporation | 2014-08-17 |
| PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to s recall (Z-2255-2014) | Ortho Development Corporation | 2014-08-17 |
| PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee Syste recall (Z-1610-2014) | Ortho Development Corporation | 2014-05-13 |
| Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Si recall (Z-1993-2009) | Ortho Development Corporation | 2009-09-09 |