FDA 510(k)

JARVIS 骨幹標準管

K 號：K253345 · 2025-10-29

決定日期2025-10-29

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

JARVIS Diaphyseal Stem Standard is the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K253345. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JARVIS Diaphyseal Stem Standard?

JARVIS Diaphyseal Stem Standard is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is FH Industrie. The 510(k) number is K253345.

When did JARVIS Diaphyseal Stem Standard receive FDA 510(k) clearance?

JARVIS Diaphyseal Stem Standard received FDA 510(k) clearance on 2025-10-29, under 510(k) number K253345.

Who is the listed applicant for JARVIS Diaphyseal Stem Standard?

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

What is the FDA product code for JARVIS Diaphyseal Stem Standard?

The FDA product code for JARVIS Diaphyseal Stem Standard is PHX.

其他以 FH Industrie 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。

K254003JARVIS 骨幹移植體 K252411JARVIS 閃淚肩關逆轉人工關節 K242253JARVIS 閃淚肩關逆轉人工關節 K232226ARROW 偏心肱骨插入物 K220758e-Ortho Shoulder 軟體 v1.1 K202024ARROW 短茎肱骨系统

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相關器械（代碼：PHX）

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。

K260556Veritas肩部系統Restor3D K261683Augment 偏心儀器系統Zimmer, Inc.K260102Tornier Perform Reversed Glenoid和Tornier Perform Reversed Augmented Glenoid Shoulder System的設備名稱Stryker Corporation (Tornier, Inc.)K261016MSS - 肱骨反覆蓋擴充件Medacta International, SA K253992Veritas逆向全肩關節系統Restor3D K252404全面反向肩蓋 - HA 髖關節基板Biomet Orthopedics

官方來源

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