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510(k) K251063

TekBrace Solo Soft Tissue Reinforcement Device by Theramicro — Product Code QUW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 30, 2025
Date Received: April 4, 2025
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.