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FDA 510(k)

Cranial PSI

K-Number: K161090 · 2017-01-19

ApplicantOssdsign AB
Decision Date2017-01-19
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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 2017-01-19 under 510(k) number K161090. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cranial PSI?

Cranial PSI is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Ossdsign AB. The 510(k) number is K161090.

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

Cranial PSI received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161090.

Who is the listed applicant for 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 Cranial PSI?

The FDA product code for Cranial PSI is GXN.

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 FillerK212414OSSDSIGN Cranial PSIK190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant TrialK181539OSSDSIGN Cranioplug

Related Devices (Code: GXN)

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.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.K243715Synthes Patient Specific ImplantsSynthes GmbHK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEKLS-Martin L.P.

Official Source

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

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