Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device— 510(k) K222978

Name: FDA 510(k) clearance K222978
Creator: U.S. Food and Drug Administration
Published: 2022-12-27

Substantially Equivalent

Xiros, Ltd.

FDA 510(k) clearance K222978 for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, Substantially Equivalent on 2022-12-27. Applicant: Xiros, Ltd.. Device class: 2.

Clearance details

Applicant: Xiros, Ltd.
Product code: Code QUW
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2022-09-28
Decision date: 2022-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

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
K251063 — TekBrace Solo Soft Tissue Reinforcement Device2025-05-30

More clearances from Xiros, Ltd.

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K230671 — Pitch PaSoft Tissue Reinforcement Device2023-05-31
K220091 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device2022-08-26
K220906 — SECURE-LOCK2022-07-22
K211563 — Pitch-Patchs2021-08-13
K191053 — Xtreme-Loop2019-07-17

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