Custom Craniofacial Implant (Cci)

FDA 510(k) K121755 · Kelyniam Global, Inc.

Substantially Equivalent

510(k) numberK121755

Submission

Device name
Custom Craniofacial Implant (Cci)
Applicant
Kelyniam Global, Inc.
Canton, CT, US
Received
June 15, 2012
Decision date
September 25, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXN – Plate, Cranioplasty, Preformed, Non-Alterable
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5330
Specialty
Neurology
Implant
Yes

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K240567CustomizedBone ServiceGXN · Special Fin-Ceramica Faenza S.P.A.03/28/2024SE
K231920Longeviti ClearFit OTS Cranial ImplantGXN · Special Longeviti Neuro Solutions, LLC11/09/2023SE
K214109PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)GXN · Traditional Kontour(Xi’An) Medical Technology Co., Ltd.10/28/2022SE
K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN · Traditional Medcad08/26/2022SE

More from Medcad

510(k)DeviceDecision
K250334Fusion Craniofacial Implant; Fusion Skull ImplantGWO · Traditional 07/25/2025SE
K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)GWO · Traditional 05/21/2019SE
K103582Kelyniam Custom Skull Implant (Csi)GXN · Traditional 04/14/2011SE

Questions and answers

When was Custom Craniofacial Implant (Cci) cleared by the FDA?

Custom Craniofacial Implant (Cci) (K121755) received a 510(k) decision of Substantially Equivalent on September 25, 2012, 102 days after the submission was received.

What is the product code of K121755?

The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.