FDA 510(k)

VELOS™ 髋關節導航系統

K 號：K253551 · 2026-03-06

決定日期2026-03-06

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

VELYS™ Hip Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2026-03-06 under 510(k) number K253551. 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 VELYS™ Hip Navigation?

VELYS™ Hip Navigation is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Depuy Ireland UC. The 510(k) number is K253551.

When did VELYS™ Hip Navigation receive FDA 510(k) clearance?

VELYS™ Hip Navigation received FDA 510(k) clearance on 2026-03-06, under 510(k) number K253551.

Who is the listed applicant for VELYS™ Hip Navigation?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELYS™ Hip Navigation?

The FDA product code for VELYS™ Hip Navigation is QIH.

其他以 Depuy Ireland UC 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。

K261458ATTUNE Total Knee System; ATTUNE Cementless Knee System K260480VELYS™ 運動輔助解決方案 K260536Prostalac 髋關節系統，SmartSet V+G雙抗生素骨水泥 K253624INHANCE™ 預後肩關節系統 K253197ATTUNE® Total Knee System; ATTUNE® Revision Sleeve LPS™ Femoral Adaptors K251292RECLAIM單塊式修復股骨柄

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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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