TekBrace Solo Soft Tissue Reinforcement Device— 510(k) K251063

Name: FDA 510(k) clearance K251063
Creator: U.S. Food and Drug Administration
Published: 2025-05-30

Substantially Equivalent

Theramicro

FDA 510(k) clearance K251063 for TekBrace Solo Soft Tissue Reinforcement Device, Substantially Equivalent on 2025-05-30. Applicant: Theramicro. Device class: 2.

Clearance details

Applicant: Theramicro
Product code: Code QUW
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2025-04-04
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QUW

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K262729 — TeKBrace Solo Soft Tissue Reinforcement Device2026-08-18
K261621 — TekBrace Solo Soft Tissue Reinforcement Device2026-06-09
K242237 — Jewel Soft Tissue Reinforcement Device (102-6005)2025-07-15
K222978 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device2022-12-27

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K253538 — TeKBrace Knotless Anchor2026-03-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.