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FDA 510(k)

Stryker CMF MEDPOR Customized Implant

K-Number: K153508 · 2016-02-05

ApplicantStryker
Decision Date2016-02-05
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Stryker CMF MEDPOR Customized Implant is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2016-02-05 under approval number K153508. 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 Customized Implant?

Stryker CMF MEDPOR Customized Implant is a medical device that received FDA 510(k) clearance on 2016-02-05. It is manufactured by Stryker. The 510(k) number is K153508.

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

Stryker CMF MEDPOR Customized Implant received FDA 510(k) clearance on 2016-02-05, under approval number K153508.

What company makes Stryker CMF MEDPOR Customized Implant?

Stryker CMF MEDPOR Customized Implant is manufactured by Stryker.

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

The FDA product code for Stryker CMF MEDPOR Customized Implant 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 NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07245810 Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up ACTIVE_NOT_RECRUITING NCT07221916 Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up COMPLETED

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Related Devices (Code: FWP)

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. 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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