FDA 510(k)

MedCAD AccuShape Titanium Patient-Specific Cranial Implant

K-번호: K220357 · 2022-08-26

신청자Medcad

결정일2022-08-26

제품 코드GXN

자문 위원회NE

결정Substantially Equivalent

기기 요약

MedCAD AccuShape Titanium Patient-Specific Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K220357. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is Medcad. The 510(k) number is K220357.

When did MedCAD AccuShape Titanium Patient-Specific Cranial Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for MedCAD AccuShape Titanium Patient-Specific Cranial Implant?

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

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.

Medcad를 신청인으로 등재한 기타 기록

K252064MedCAD® AccuStride™ System K251709MedCAD® AccuStride™ System K241811MedCAD® AccuStride™ System K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating System K223421MedCAD AccuPlan Orthopedics System K223024MedCAD AccuPlan System

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관련 기기 (코드: GXN)

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 Solutions K2531163D 맥티움 타이타늄 뇌골판 (TCP) 시스템The 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 GmbH K252573KLS 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.

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