Artelon Convenience Kits— 510(k) K260317
Substantially EquivalentInternational Life Sciences
FDA 510(k) clearance K260317 for Artelon Convenience Kits, Substantially Equivalent on 2026-04-09. Applicant: International Life Sciences. Device class: 2.
Summary
Artelon Convenience Kits are filed under QWJ, resorbable polymeric surgical mesh for reinforcing ligaments in orthopedic repairs. The code covers reinforcement of soft tissue where weakness exists in ligament repair. The record doesn't list what the kits contain.
Class II, 21 CFR 878.3300, filed as a Traditional 510(k). The record lists General and Plastic Surgery as the advisory panel and Orthopedic as the review panel.
International Life Sciences filed from Sandy Springs, Georgia. Review took 69 days (January 30 to April 9, 2026).
Clearance details
- Applicant
- International Life Sciences
- Product code
- Product code QWJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandy Springs, GA, US
More clearances from International Life Sciences
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