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FDA 510(k)

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 · 2019-10-10

ApplicantOssdsign AB
Decision Date2019-10-10
Product CodePJN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial is a medical device manufactured by Ossdsign AB. It received FDA 510(k) clearance on 2019-10-10 under approval number K190523. The device is classified under product code PJN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial?

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Ossdsign AB. The 510(k) number is K190523.

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 approved 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 received FDA 510(k) clearance on 2019-10-10, under approval number K190523.

What company makes Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial?

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial is manufactured by Ossdsign AB.

What is the FDA product code for Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial?

The FDA product code for Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial is PJN.

Related Clinical Trials

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Related PubMed Literature

PMID: 32309074 Postmarket Modifications of High-risk Plastic Surgery Devices. Plastic and reconstructive surgery. Global open (2020) PMID: 26056630 Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. International journal of spine surgery (2015)

Other Devices by Ossdsign AB

K161090Cranial PSI K181539OSSDSIGN Cranioplug K212414OSSDSIGN Cranial PSI K232315Catalyst Bone Void Filler

Related Devices (Code: PJN)

K212414OSSDSIGN Cranial PSIOssdsign AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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