FDA 510(k)

Augment 偏心儀器系統

K 號：K261683 · 2026-06-16

決定日期2026-06-16

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

Augment Off-Axis Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K261683. 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 Augment Off-Axis Instrument System?

Augment Off-Axis Instrument System is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Zimmer, Inc.. The 510(k) number is K261683.

When did Augment Off-Axis Instrument System receive FDA 510(k) clearance?

Augment Off-Axis Instrument System received FDA 510(k) clearance on 2026-06-16, under 510(k) number K261683.

Who is the listed applicant for Augment Off-Axis Instrument System?

FDA 510(k) 記錄將 Zimmer, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Augment Off-Axis Instrument System?

The FDA product code for Augment Off-Axis Instrument System is PHX.

其他以 Zimmer, Inc. 為申請人之記錄

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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 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 K260583Equinoxe® 肩關節系統Exactech, Inc.

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