FDA 510(k)

Inion 压縮釘

K 號：K203105 · 2021-01-13

決定日期2021-01-13

產品代碼HWC

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決定相當於

器材摘要

Inion CompressOn Screw is the device name listed in this FDA 510(k) record. The listed applicant is Inion OY. It received FDA 510(k) clearance on 2021-01-13 under 510(k) number K203105. 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.

常見問題

What is the Inion CompressOn Screw?

Inion CompressOn Screw is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Inion OY. The 510(k) number is K203105.

When did Inion CompressOn Screw receive FDA 510(k) clearance?

Inion CompressOn Screw received FDA 510(k) clearance on 2021-01-13, under 510(k) number K203105.

Who is the listed applicant for Inion CompressOn Screw?

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

What is the FDA product code for Inion CompressOn Screw?

The FDA product code for Inion CompressOn Screw is HWC. This falls under the Cardiovascular category.

其他以 Inion OY 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251441Inion CPS 1.5 婴兒生物可吸收固定系統；Inion CPS 1.5/2.0/2.5 生物可吸收固定系統 K251472Inion CPS 1.5/2.0/2.5 生化吸收固定系統；Inion CPS 1.5 幼兒生化吸收固定系統 K191764Inion BioRestore

相關器械（代碼：HWC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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