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FDA 510(k)

OSSIOfiber 压縮螺釘，OSSIOfiber 压縮螺釘，6.5mm

K 號：K221193 · 2022-12-23

申請人OSSIO , Ltd.
決定日期2022-12-23
產品代碼HWC
諮詢委員會或
決定相當於

器材摘要

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K221193. 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 Screw, OSSIOfiber Compression Screw, 6.5mm?

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is OSSIO , Ltd.. The 510(k) number is K221193.

When did OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm receive FDA 510(k) clearance?

OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm received FDA 510(k) clearance on 2022-12-23, under 510(k) number K221193.

Who is the listed applicant for OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm?

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 Screw, OSSIOfiber Compression Screw, 6.5mm?

The FDA product code for OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm is HWC. This falls under the Cardiovascular category.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 mmK241932OSSIOfiber® 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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官方來源

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