Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Ossdsign AB. It received FDA 510(k) clearance on 2021-10-01 under 510(k) 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. The listed applicant is Ossdsign AB. The 510(k) number is K212414.

When did OSSDSIGN Cranial PSI receive FDA 510(k) clearance?

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

Who is the listed applicant for OSSDSIGN Cranial PSI?

The FDA 510(k) record lists Ossdsign AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSDSIGN Cranial PSI?

The FDA product code for OSSDSIGN Cranial PSI is PJN.

Other records listing Ossdsign AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232315Catalyst Bone Void FillerK190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant TrialK181539OSSDSIGN CranioplugK161090Cranial PSI

Related Devices (Code: PJN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

↑