QVV — Medial Knee Implanted Shock Absorber Class II
FDA product code QVV covers "Medial Knee Implanted Shock Absorber", a Class II medical device regulated under 21 CFR 888.3610. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QVV
- Device Class
- Class II
- Regulation Number
- 888.3610
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220033 | moximed | MISHA Knee System | April 10, 2023 |