FDA 510(k)

OIC 内髄釘システム

K番号: K223761 · 2023-02-13

決定日2023-02-13

製品コードHWC

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。

決定大幅同等

医療機器の概要

OIC Intramedullary Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Implant Company. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K223761. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the OIC Intramedullary Screw System?

OIC Intramedullary Screw System is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Orthopaedic Implant Company. The 510(k) number is K223761.

When did OIC Intramedullary Screw System receive FDA 510(k) clearance?

OIC Intramedullary Screw System received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223761.

Who is the listed applicant for OIC Intramedullary Screw System?

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

What is the FDA product code for OIC Intramedullary Screw System?

The FDA product code for OIC Intramedullary Screw System is HWC. This falls under the Cardiovascular category.

申請者としてOrthopaedic Implant Companyを記載するその他の記録

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