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FDA 510(k)

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

K-Number: K182711 · 2019-05-21

ApplicantKelyniam Global, Inc.
Decision Date2019-05-21
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) is a medical device manufactured by Kelyniam Global, Inc.. It received FDA 510(k) clearance on 2019-05-21 under approval number K182711. 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 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)?

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) is a medical device that received FDA 510(k) clearance on 2019-05-21. It is manufactured by Kelyniam Global, Inc.. The 510(k) number is K182711.

When was Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) approved by the FDA?

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) received FDA 510(k) clearance on 2019-05-21, under approval number K182711.

What company makes Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)?

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) is manufactured by Kelyniam Global, Inc..

What is the FDA product code for Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)?

The FDA product code for Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) 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 NCT05393622 Brain Stimulation for Severe Depression RECRUITING

Other Devices by Kelyniam Global, Inc.

K250334Fusion Craniofacial Implant; Fusion Skull Implant

Related Devices (Code: GWO)

K161821Stryker Universal MeshStryker K161446Biopor Porous Polyethylene ImplantsCeremed , Inc. K153248PEEK Customized Cranial ImplantStryker K170725Stryker Universal MeshStryker K170368Sterile NS SystemJeil Medical Corporation K182425Universal Mesh - SterileStryker 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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