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FDA 510(k)

MedCAD AccuShape Titanium Patient-Specific Cranial Implant

K-Number: K220357 · 2022-08-26

ApplicantMedcad
Decision Date2022-08-26
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MedCAD AccuShape Titanium Patient-Specific Cranial Implant is a medical device manufactured by Medcad. It received FDA 510(k) clearance on 2022-08-26 under approval number K220357. 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 MedCAD AccuShape Titanium Patient-Specific Cranial Implant?

MedCAD AccuShape Titanium Patient-Specific Cranial Implant is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Medcad. The 510(k) number is K220357.

When was MedCAD AccuShape Titanium Patient-Specific Cranial Implant approved by the FDA?

MedCAD AccuShape Titanium Patient-Specific Cranial Implant received FDA 510(k) clearance on 2022-08-26, under approval number K220357.

What company makes MedCAD AccuShape Titanium Patient-Specific Cranial Implant?

MedCAD AccuShape Titanium Patient-Specific Cranial Implant is manufactured by Medcad.

What is the FDA product code for MedCAD AccuShape Titanium Patient-Specific Cranial Implant?

The FDA product code for MedCAD AccuShape Titanium Patient-Specific Cranial Implant is GXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026)

Other Devices by Medcad

K192282MedCAD® AccuPlan® System K193280MedCAD® AccuPlate® Patient-Specific Plate K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating System K223421MedCAD AccuPlan Orthopedics System K223024MedCAD AccuPlan System K251709MedCAD® AccuStride™ System

View all 9 devices →

Related Devices (Code: GXN)

K160707CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K171507CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K161090Cranial PSIOssdsign AB K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc. K180513CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC

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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