510(k) K242237
K242237 is an FDA 510(k) premarket notification submitted by Xiros Limited for the device "Jewel Soft Tissue Reinforcement Device (102-6005)". The FDA issued a decision of Substantially Equivalent on July 15, 2025. The device falls under product code QUW (Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament), a Class II device regulated under 21 CFR 878.3300.
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.