510(k) K260317
K260317 is an FDA 510(k) premarket notification submitted by International Life Sciences for the device "Artelon Convenience Kits". The FDA issued a decision of Substantially Equivalent on April 9, 2026. The device falls under product code QWJ (Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament), a Class II device regulated under 21 CFR 878.3300. International Life Sciences has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2026
- Date Received
- January 30, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
For reinforcement of soft tissue where weakness exists in ligament repair