3D KNEE
FDA 510(k) clearance K020114 · decided 2002-07-12
Clearance details
- K-number
- K020114
- Device name
- 3D KNEE
- Applicant
- Encore Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-11
- Decision date
- 2002-07-12
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003. recall (Z-2244-2010) | Encore Medical, Lp | 2010-08-22 |
| 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, L recall (Z-1433-2010) | Encore Medical, Lp | 2010-04-26 |
| 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore M recall (Z-1539-2008) | Encore Medical, Lp | 2008-08-20 |
| Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement. recall (Z-0332-06) | Encore Medical, Lp | 2005-12-29 |
| 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore recall (Z-1011-04) | Encore Medical, LP | 2004-07-20 |