FDA 510(k)

OsseoFit 接口樁；OsseoFit 骨隧道結構

K 號：K242494 · 2024-11-26

決定日期2024-11-26

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K242494. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct?

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Riverpoint Medical, LLC. The 510(k) number is K242494.

When did OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct receive FDA 510(k) clearance?

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242494.

Who is the listed applicant for OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct?

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

What is the FDA product code for OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct?

The FDA product code for OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct is MBI.

其他以 Riverpoint Medical, LLC 為申請人之記錄

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相關器械（代碼：MBI）

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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