510(k) K253867
K253867 is an FDA 510(k) premarket notification submitted by ZuriMED Technologies AG for the device "FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit". The FDA issued a decision of Substantially Equivalent on January 2, 2026. The device falls under product code OWX (Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300. ZuriMED Technologies AG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 2026
- Date Received
- December 3, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
For reinforcement of soft tissue where weakness exists in tendon repair.