FDA 510(k)

DeGen Medical Patient Specific Implant (PSI) System

K番号: K251829 · 2025-12-08

決定日2025-12-08

製品コードOVD

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定Substantially Equivalent

医療機器の概要

DeGen Medical Patient Specific Implant (PSI) System is the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2025-12-08 under 510(k) number K251829. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the DeGen Medical Patient Specific Implant (PSI) System?

DeGen Medical Patient Specific Implant (PSI) System is a medical device that received FDA 510(k) clearance on 2025-12-08. The listed applicant is Degen Medical. The 510(k) number is K251829.

When did DeGen Medical Patient Specific Implant (PSI) System receive FDA 510(k) clearance?

DeGen Medical Patient Specific Implant (PSI) System received FDA 510(k) clearance on 2025-12-08, under 510(k) number K251829.

Who is the listed applicant for DeGen Medical Patient Specific Implant (PSI) System?

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

What is the FDA product code for DeGen Medical Patient Specific Implant (PSI) System?

The FDA product code for DeGen Medical Patient Specific Implant (PSI) System is OVD.

申請者としてDegen Medicalを記載するその他の記録

K252737DeGen Medical Latitude-C AM 頸椎間融合システム K250667DeGen Medical Patient Specific Implant (PSI) System K241077DeGen Medical Patient Specific Implant (PSI) System K231199Solar Lumbar Interbody Fusion System K223418デジェン・インパルスAM™ システム K213918デジェン・ナビゲートド・インストルメンテーション

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公式ソース

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