FDA 510(k)

簽名ONE系統

K 號：K192074 · 2019-08-30

決定日期2019-08-30

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 2019-08-30 under 510(k) number K192074. 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 2019-08-30. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K192074.

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

Signature ONE System received FDA 510(k) clearance on 2019-08-30, under 510(k) number K192074.

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

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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

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