VKS KNEE SYSTEM
FDA 510(k) clearance K022204 · decided 2002-10-18
Clearance details
- K-number
- K022204
- Device name
- VKS KNEE SYSTEM
- Applicant
- Plus Orthopedics
- Decision
- Substantially Equivalent
- Date received
- 2002-07-05
- Decision date
- 2002-10-18
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Ortho recall (Z-0361-2008) | Plus Orthopedics USA | 2007-12-08 |
| VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and recall (Z-0397-06) | Plus Orthopedics USA | 2006-01-18 |
| Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807 recall (Z-0924-05) | Plus Orthopedics USA | 2005-06-22 |
| UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, recall (Z-0540-05) | Plus Orthopedics | 2005-02-15 |