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FDA 510(k)

Stryker CMF MEDPOR Priority Customized Implant Kit

K-Number: K191916 · 2019-08-15

ApplicantStryker Leibinger GmbH & Co KG
Decision Date2019-08-15
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Stryker CMF MEDPOR Priority Customized Implant Kit is a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2019-08-15 under approval number K191916. 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 Stryker CMF MEDPOR Priority Customized Implant Kit?

Stryker CMF MEDPOR Priority Customized Implant Kit is a medical device that received FDA 510(k) clearance on 2019-08-15. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K191916.

When was Stryker CMF MEDPOR Priority Customized Implant Kit approved by the FDA?

Stryker CMF MEDPOR Priority Customized Implant Kit received FDA 510(k) clearance on 2019-08-15, under approval number K191916.

What company makes Stryker CMF MEDPOR Priority Customized Implant Kit?

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

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

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

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07245758 Facial iD Customized Mandible Reconstruction Plates COMPLETED

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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. K200610Customized Contour ImplantImplantech Associates, Inc. K232593FITme Customized Silicone ImplantKeosan Trading Co. K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG

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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