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510(k) K253867

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit by ZuriMED Technologies AG — Product Code OWX

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.