FDA 510(k)

DePuy Synthes VOLT™ 髌骨遠端股骨 3.5 補板系統

K 號：K254093 · 2026-03-10

決定日期2026-03-10

產品代碼HRS

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器材摘要

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes GmbH. It received FDA 510(k) clearance on 2026-03-10 under 510(k) number K254093. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System?

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Synthes GmbH. The 510(k) number is K254093.

When did DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System receive FDA 510(k) clearance?

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System received FDA 510(k) clearance on 2026-03-10, under 510(k) number K254093.

Who is the listed applicant for DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System?

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

What is the FDA product code for DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System?

The FDA product code for DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is HRS.

其他以 Synthes GmbH 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。

K260069DePuy Synthes VOLT™ 膝蓋上胫骨 3.5 補板系統 K254054VOLT™ 腳踝創傷 2.7/3.5 板金系統；VOLT™ 頚骨 2.7 板金系統 K243715Synthes 個體化植入物 K241927合成圖形外殼及托盤系統 K233994VOLT™ 近端肱骨 3.5 套管系統 K233967DePuy Synthes 矢狹板固定系統

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相關器械（代碼：HRS）

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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