Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

FDA 510(k) K190523 · Ossdsign AB

Substantially Equivalent

510(k) numberK190523

Submission

Device name
Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
Applicant
Ossdsign AB
Uppsala, SE
Received
March 4, 2019
Decision date
October 10, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PJN – Filler, Bone Void, Non-Alterable Compound For Cranioplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5330
Specialty
Neurology
Implant
Yes

A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the…

Other 510(k)s with product code PJN

510(k)DeviceApplicantDecision
K212414OSSDSIGN Cranial PSIPJN · Traditional Ossdsign AB10/01/2021SE

More from Ossdsign AB

510(k)DeviceDecision
K232315Catalyst Bone Void FillerMQV · Traditional 09/15/2023SE
K212414OSSDSIGN Cranial PSIPJN · Traditional 10/01/2021SE
K181539OSSDSIGN CranioplugGXR · Traditional 10/12/2018SE
K161090Cranial PSIGXN · Traditional 01/19/2017SE
K140309CranioplugGXR · Traditional 10/03/2014SE

Questions and answers

When was Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial cleared by the FDA?

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial (K190523) received a 510(k) decision of Substantially Equivalent on October 10, 2019, 220 days after the submission was received.

What is the product code of K190523?

The FDA product code is PJN – Filler, Bone Void, Non-Alterable Compound For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5330.