FDA 510(k)

OSSIOfiber™ 压縮螺釘

K 號：K193660 · 2020-07-30

決定日期2020-07-30

產品代碼HWC

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器材摘要

OSSIOfiber™ Compression Screws is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K193660. 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 OSSIOfiber™ Compression Screws?

OSSIOfiber™ Compression Screws is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is OSSIO , Ltd.. The 510(k) number is K193660.

When did OSSIOfiber™ Compression Screws receive FDA 510(k) clearance?

OSSIOfiber™ Compression Screws received FDA 510(k) clearance on 2020-07-30, under 510(k) number K193660.

Who is the listed applicant for OSSIOfiber™ Compression Screws?

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

What is the FDA product code for OSSIOfiber™ Compression Screws?

The FDA product code for OSSIOfiber™ Compression Screws is HWC. This falls under the Cardiovascular category.

其他以 OSSIO , Ltd. 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。

K254077OSSIOfiber® 穿釘可調節固定釘 K254055OSSIOfiber® 緝線墊板 K252022OSSIOfiber® 交叉螺釘 K251309OSSIOfiber® 緝線墊板 K243760OSSIOfiber® 緝線墊板 2.5-3.5 mm K241932OSSIOfiber® 压縮釘

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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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