FDA 510(k)

OrthoGrid 髋關節 AI® 4.0

K 號：K260077 · 2026-05-29

決定日期2026-05-29

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

OrthoGrid Hip AI® 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is OrthoGrid Systems, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K260077. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OrthoGrid Hip AI® 4.0?

OrthoGrid Hip AI® 4.0 is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is OrthoGrid Systems, Inc.. The 510(k) number is K260077.

When did OrthoGrid Hip AI® 4.0 receive FDA 510(k) clearance?

OrthoGrid Hip AI® 4.0 received FDA 510(k) clearance on 2026-05-29, under 510(k) number K260077.

Who is the listed applicant for OrthoGrid Hip AI® 4.0?

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

What is the FDA product code for OrthoGrid Hip AI® 4.0?

The FDA product code for OrthoGrid Hip AI® 4.0 is QIH.

其他以 OrthoGrid Systems, Inc. 為申請人之記錄

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K210136幻影MSK 髋 K192279幻影MSK創傷 K182332幻影MSK

相關器械（代碼：QIH）

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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