QUW — Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament Class II
FDA product code QUW covers "Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QUW
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262729 | Theramicro | TeKBrace Solo Soft Tissue Reinforcement Device | Aug 18, 2026 |
| K261621 | Theramicro | TekBrace Solo Soft Tissue Reinforcement Device | Jun 9, 2026 |
| K242237 | Xiros Limited | Jewel Soft Tissue Reinforcement Device (102-6005) | Jul 15, 2025 |
| K251063 | Theramicro | TekBrace Solo Soft Tissue Reinforcement Device | May 30, 2025 |
| K222978 | Xiros | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Dec 27, 2022 |