Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OSSDSIGN Cranial PSI

K-Number: K212414 · 2021-10-01

ApplicantOssdsign AB
Decision Date2021-10-01
Product CodePJN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSSDSIGN Cranial PSI is a medical device manufactured by Ossdsign AB. It received FDA 510(k) clearance on 2021-10-01 under approval number K212414. 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 OSSDSIGN Cranial PSI?

OSSDSIGN Cranial PSI is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Ossdsign AB. The 510(k) number is K212414.

When was OSSDSIGN Cranial PSI approved by the FDA?

OSSDSIGN Cranial PSI received FDA 510(k) clearance on 2021-10-01, under approval number K212414.

What company makes OSSDSIGN Cranial PSI?

OSSDSIGN Cranial PSI is manufactured by Ossdsign AB.

What is the FDA product code for OSSDSIGN Cranial PSI?

The FDA product code for OSSDSIGN Cranial PSI is PJN.

Other Devices by Ossdsign AB

K161090Cranial PSI K181539OSSDSIGN Cranioplug K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial K232315Catalyst Bone Void Filler

Related Devices (Code: PJN)

K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant TrialOssdsign 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.

↑