FDA 510(k)

Signature™ ONE 系統

K 號：K232425 · 2023-12-12

決定日期2023-12-12

產品代碼QHE

諮詢委員會或

決定相當於

器材摘要

Signature™ ONE System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc. (D/B/A) Zimmer Cas). It received FDA 510(k) clearance on 2023-12-12 under 510(k) number K232425. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Signature™ ONE System?

Signature™ ONE System is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Orthosoft Inc. (D/B/A) Zimmer Cas). The 510(k) number is K232425.

When did Signature™ ONE System receive FDA 510(k) clearance?

Signature™ ONE System received FDA 510(k) clearance on 2023-12-12, under 510(k) number K232425.

Who is the listed applicant for Signature™ ONE System?

The FDA 510(k) record lists Orthosoft Inc. (D/B/A) Zimmer Cas) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signature™ ONE System?

The FDA product code for Signature™ ONE System is QHE.

其他以 Orthosoft Inc. (D/B/A) Zimmer Cas) 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。

K261510Signature™ ONE 系統 K260582ROSA® 肩關節系統 K260104Signature™ ONE 系統 K251314羅莎® 髋關節系統 K242864ROSA® 髋關節系統 K233199ROSA® 肩關節系統

查看所有 20 項裝置 →

相關器械（代碼：QHE）

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。

K260802Materialise Shoulder System™，Materialise Shoulder Guide 及 Model，SurgiCase Shoulder PlannerMaterialise NV K261510Signature™ ONE 系統Orthosoft Inc. (d/b/a) Zimmer CAS K260104Signature™ ONE 系統Orthosoft Inc. (d/b/a) Zimmer CAS K251558精準人工智慧外科計劃系統（PAI-SPS）Precision AI Pty, Ltd.K243509Archer PSI 系統3D-Side K241470核心肩部系統LinkBio Corp.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。