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510(k) K242237

Jewel Soft Tissue Reinforcement Device (102-6005) by Xiros Limited — Product Code QUW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 15, 2025
Date Received: July 30, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Device Class: Class II
Regulation Number: 878.3300
Review Panel: OR
Submission Type

a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.