Home / 510(k) Clearances / K260317

510(k) K260317

Artelon Convenience Kits by International Life Sciences — Product Code QWJ

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