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510(k) K243480

SuturePatch Tissue Reinforcement by Arthrex, Inc. — Product Code OWX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2025
Date Received
November 8, 2024
Clearance Type
Traditional
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.

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