MEDPOR Customized Implant Kit— 510(k) K254233

Name: FDA 510(k) clearance K254233
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Stryker Leibinger GmbH & Co KG

FDA 510(k) clearance K254233 for MEDPOR Customized Implant Kit, Substantially Equivalent on 2026-03-12. Applicant: Stryker Leibinger GmbH & Co KG. Device class: 2.

Clearance details

Applicant: Stryker Leibinger GmbH & Co KG
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 2025-12-29
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Frieburg, DE

Download summary PDF View on FDA.gov ↗

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