Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
The resorbable polymeric orthopedic surgical mesh for ligament reinforcement (product code QWJ) is a Class 2 implantable device classified under General, Plastic Surgery (regulation 878.3300) intended for reinforcement of soft tissue where weakness exists in ligament repair. It requires 510(k) clearance. As an implantable resorbable mesh, it is placed within the body to provide mechanical support to weakened ligamentous tissue but is not life-sustaining.
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Basic Information
- Product Code
- QWJ
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
For reinforcement of soft tissue where weakness exists in ligament repair
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260317 | Artelon Convenience Kits | Apr 09, 2026 | Substantially Equivalent | International Life Sciences |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.