OWX

Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

Product code
OWX
Device name
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
5

FDA classification definition

For reinforcement of soft tissue where weakness exists in tendon repair.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-01-02.

NumberDecision dateApplicantDevice nameSummary
K2538672026-01-02ZuriMED Technologies AGFiberLocker Implant ; FiberLocker Instrument ; FiberPDF
K2509972025-06-17Anika Therapeutics, Inc.Integrity™ ImplantPDF
K2434802025-05-29Arthrex, Inc.SuturePatch Tissue ReinforcementPDF
K2412192024-12-11ZuriMED Technologies AGFiberLocker System: FiberLocker Implant (SpeedPatch PDF

4 summaries are archived here for direct download.

Official FDA classification page: OWX
Classification and pathway per current FDA publications. Data from openFDA (CC0).