QWJ — Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament Class II
FDA product code QWJ covers "Mesh, Surgical, Polymeric, 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 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWJ
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists in ligament repair
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260317 | international life sciences | Artelon Convenience Kits | April 9, 2026 |