Cranial PSI

FDA 510(k) K161090 · Ossdsign AB

Substantially Equivalent

510(k) numberK161090

Submission

Device name
Cranial PSI
Applicant
Ossdsign AB
Uppsala, SE
Received
April 18, 2016
Decision date
January 19, 2017
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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K243715Synthes Patient Specific ImplantsGXN · Traditional Synthes GmbH11/12/2025SE
K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional KLS-Martin L.P.11/10/2025SE
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
K232315Catalyst Bone Void FillerMQV · Traditional 09/15/2023SE
K212414OSSDSIGN Cranial PSIPJN · Traditional 10/01/2021SE
K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical…PJN · Traditional 10/10/2019SE
K181539OSSDSIGN CranioplugGXR · Traditional 10/12/2018SE
K140309CranioplugGXR · Traditional 10/03/2014SE

Questions and answers

When was Cranial PSI cleared by the FDA?

Cranial PSI (K161090) received a 510(k) decision of Substantially Equivalent on January 19, 2017, 276 days after the submission was received.

What is the product code of K161090?

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