QUW — Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament Class II
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 |
|---|---|---|---|
| K242237 | xiros limited | Jewel Soft Tissue Reinforcement Device (102-6005) | July 15, 2025 |
| K251063 | theramicro | TekBrace Solo Soft Tissue Reinforcement Device | May 30, 2025 |
| K222978 | xiros | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | December 27, 2022 |