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

K Number: K190523 · Decision Oct 10, 2019

Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

Review Days

220

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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
K Number: K190523
Device Class: FDA class 2
Clearance Type: Traditional
Regulation Number: 882.5330
Medical Specialty: Neurology
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: Ossdsign AB
Date Received: March 4, 2019
Decision Date: October 10, 2019
Product Code: PJN
Advisory Committee: Neurology
Review Advisory Committee: NE
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	FDA class 2	Neurology

Other 510(k) clearances with the same product code (PJN), ordered by most recent decision date.

View all

K Number	Device Name	Decision Date	Decision
K232315	Catalyst Bone Void Filler	Sep 15, 2023	Substantially Equivalent
K212414	OSSDSIGN Cranial PSI	Oct 1, 2021	Substantially Equivalent
K181539	OSSDSIGN Cranioplug	Oct 12, 2018	Substantially Equivalent
K161090	Cranial PSI	Jan 19, 2017	Substantially Equivalent
K140309	CRANIOPLUG	Oct 3, 2014	Substantially Equivalent