QUW
- Product code
- QUW
- Device name
- Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
FDA classification definition
a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262729 | 2026-08-18 | Theramicro | TeKBrace Solo Soft Tissue Reinforcement Device | |
| K261621 | 2026-06-09 | Theramicro | TekBrace Solo Soft Tissue Reinforcement Device | |
| K242237 | 2025-07-15 | Xiros Limited | Jewel Soft Tissue Reinforcement Device (102-6005) | |
| K251063 | 2025-05-30 | Theramicro | TekBrace Solo Soft Tissue Reinforcement Device |
Official FDA classification page: QUW
Classification and pathway per current FDA publications. Data from openFDA (CC0).