FiberLocker Implant; FiberLocker Instrument; FiberLocker PowerUnit— 510(k) K253867

Name: FDA 510(k) clearance K253867
Creator: U.S. Food and Drug Administration
Published: 2026-01-02

Substantially Equivalent

ZuriMED Technologies AG

FDA 510(k) clearance K253867 for FiberLocker Implant; FiberLocker Instrument; FiberLocker PowerUnit, Substantially Equivalent on 2026-01-02. Applicant: ZuriMED Technologies AG. Device class: 2.

Clearance details

Device name as filed: FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
Applicant: ZuriMED Technologies AG
Product code: Code OWX
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2025-12-03
Decision date: 2026-01-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

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K223538 — Integrity Implant2023-08-17

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