FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)— 510(k) K241219

Name: FDA 510(k) clearance K241219
Creator: U.S. Food and Drug Administration
Published: 2024-12-11

Substantially Equivalent

ZuriMED Technologies AG

FDA 510(k) clearance K241219 for FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN), Substantially Equivalent on 2024-12-11. Applicant: ZuriMED Technologies AG. Device class: 2.

Clearance details

Applicant: ZuriMED Technologies AG
Product code: Code OWX
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2024-05-01
Decision date: 2024-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

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