QVVClass II
Medial Knee Implanted Shock Absorber
21 CFR 888.3610 / Orthopedic
QVV is the FDA product code for Medial Knee Implanted Shock Absorber, a class II device type, regulated under 21 CFR 888.3610. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- QVV
- Device name
- Medial Knee Implanted Shock Absorber
- FDA 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.
- Regulation
- 21 CFR 888.3610
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code QVV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
Applicants with the most clearances
Product code QVV| Applicant | Clearances |
|---|---|
| Moximed, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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