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FDA 510(k)

OSSIOfiber 穿刺可調節固定釘，OSSIOfiber 可調節固定釘，OSSIOfiber 可調節固定釘，穿刺設計

K 號：K203465 · 2021-01-06

申請人OSSIO , Ltd.
決定日期2021-01-06
產品代碼HTY
諮詢委員會或
決定相當於

器材摘要

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K203465. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is OSSIO , Ltd.. The 510(k) number is K203465.

When did OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design receive FDA 510(k) clearance?

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design received FDA 510(k) clearance on 2021-01-06, under 510(k) number K203465.

Who is the listed applicant for OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

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 Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design?

The FDA product code for OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design is HTY.

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：HTY）

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。

K262722原始K釘（P99-193-1410）Paragon 28, Inc.K253325ZipToe™ 間趾融合系統Toetal SolutionsK252657影響 PEEK 聯合釘系統Nvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ 強韌指甲系統OrthoPediatrics Corp.K250646影響 PEEK 聯合釘系統Nvision Biomedical Technologies

官方來源

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