SECURE-LOCK— 510(k) K220906

Name: FDA 510(k) clearance K220906
Creator: U.S. Food and Drug Administration
Published: 2022-07-22

Substantially Equivalent

Xiros, Ltd.

FDA 510(k) clearance K220906 for SECURE-LOCK, Substantially Equivalent on 2022-07-22. Applicant: Xiros, Ltd.. Device class: 2.

Clearance details

Applicant: Xiros, Ltd.
Product code: Product code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2022-03-29
Decision date: 2022-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Xiros, Ltd.

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

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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