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FDA 510(k)

MEDPOR Customized Implant Kit

K-Number: K254233 · 2026-03-12

ApplicantStryker Leibinger GmbH & Co KG
Decision Date2026-03-12
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDPOR Customized Implant Kit is a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2026-03-12 under approval number K254233. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDPOR Customized Implant Kit?

MEDPOR Customized Implant Kit is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K254233.

When was MEDPOR Customized Implant Kit approved by the FDA?

MEDPOR Customized Implant Kit received FDA 510(k) clearance on 2026-03-12, under approval number K254233.

What company makes MEDPOR Customized Implant Kit?

MEDPOR Customized Implant Kit is manufactured by Stryker Leibinger GmbH & Co KG.

What is the FDA product code for MEDPOR Customized Implant Kit?

The FDA product code for MEDPOR Customized Implant Kit is FWP.

Related Clinical Trials

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Related Devices (Code: FWP)

K153508Stryker CMF MEDPOR Customized ImplantStryker K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC K191130Customized Contour ImplantImplantech Associates, Inc. K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG K200610Customized Contour ImplantImplantech Associates, Inc. K232593FITme Customized Silicone ImplantKeosan Trading Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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