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FDA 510(k)

PEEK Customized Cranial Implant

K-Number: K153248 · 2016-03-10

ApplicantStryker
Decision Date2016-03-10
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PEEK Customized Cranial Implant is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2016-03-10 under approval number K153248. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEK Customized Cranial Implant?

PEEK Customized Cranial Implant is a medical device that received FDA 510(k) clearance on 2016-03-10. It is manufactured by Stryker. The 510(k) number is K153248.

When was PEEK Customized Cranial Implant approved by the FDA?

PEEK Customized Cranial Implant received FDA 510(k) clearance on 2016-03-10, under approval number K153248.

What company makes PEEK Customized Cranial Implant?

PEEK Customized Cranial Implant is manufactured by Stryker.

What is the FDA product code for PEEK Customized Cranial Implant?

The FDA product code for PEEK Customized Cranial Implant is GWO.

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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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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