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510(k) K261621

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 9, 2026
Date Received: May 15, 2026
Clearance Type: Special
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.