510(k) K190523

Device: 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
510(k) number: K190523
Product code: PJN
Decision: Substantially Equivalent (SESE)
Decision date: 2019-10-10
Date received: 2019-03-04
Regulation: 882.5330
Classification name: Filler, Bone Void, Non-alterable Compound For Cranioplasty
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Ulrik Birgersson
Address: Virdings Alle 2 Uppsala SE SE 754 50 SE 754 50

FDA Registration Numbers#

1064858
3014680740
3015259858
3006130229
3010407203

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
17350086550426	Anatomical Model Original	Ossdsign AB	2020-07-03
17350086550433	Anatomical Model Original	Ossdsign AB	2020-07-03
17350086550501	Anatomical Model Modified	Ossdsign AB	2020-07-03
17350086550518	Anatomical Model Modified	Ossdsign AB	2020-07-03
17350086550532	Plastic Drawing Guide	Ossdsign AB	2020-01-22
07350086550603	Anatomical Model Original	Ossdsign AB	2020-01-22
07350086550610	Anatomical Model Original	Ossdsign AB	2020-01-22
07350086550627	Anatomical Model Original	Ossdsign AB	2020-01-22
07350086550634	Anatomical Model Original	Ossdsign AB	2020-01-22
07350086550641	Anatomical Model Modified	Ossdsign AB	2020-01-22
07350086550658	Anatomical Model Modified	Ossdsign AB	2020-01-22
07350086550665	Anatomical Model Modified	Ossdsign AB	2020-01-22
07350086550672	Anatomical Model Modified	Ossdsign AB	2020-01-22
17350086550525	Plastic Drawing Guide	Ossdsign AB	2020-01-22
17350086550679	Anatomical Model Modified	Ossdsign AB	2020-01-22
17350086550549	Plastic Drawing Guide	Ossdsign AB	2020-01-22
17350086550556	Plastic Drawing Guide	Ossdsign AB	2020-01-22
17350086550563	Cranial Implant Trial	Ossdsign AB	2020-01-22
17350086550570	Cranial Implant Trial	Ossdsign AB	2020-01-22
17350086550587	Cranial Implant Trial	Ossdsign AB	2020-01-22
17350086550594	Cranial Implant Trial	Ossdsign AB	2020-01-22
17350086550600	Anatomical Model Original	Ossdsign AB	2020-01-22
17350086550617	Anatomical Model Original	Ossdsign AB	2020-01-22
17350086550624	Anatomical Model Original	Ossdsign AB	2020-01-22
17350086550631	Anatomical Model Original	Ossdsign AB	2020-01-22
17350086550648	Anatomical Model Modified	Ossdsign AB	2020-01-22
17350086550655	Anatomical Model Modified	Ossdsign AB	2020-01-22
17350086550662	Anatomical Model Modified	Ossdsign AB	2020-01-22

Other 510(k) Records For Product Code PJN #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K212414	OSSDSIGN Cranial PSI	Ossdsign AB	2021-10-01

Legacy Summary#

summary

FDA Review#

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