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FDA 510(k)

Active-X Total Knee System

K 號：K160159 · 2016-09-06

申請人Signature Orthopaedics Pty, Ltd.
決定日期2016-09-06
產品代碼JWH
諮詢委員會OR
決定Substantially Equivalent

器材摘要

Active-X Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K160159. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Active-X Total Knee System?

Active-X Total Knee System is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K160159.

When did Active-X Total Knee System receive FDA 510(k) clearance?

Active-X Total Knee System received FDA 510(k) clearance on 2016-09-06, under 510(k) number K160159.

Who is the listed applicant for Active-X Total Knee System?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Active-X Total Knee System?

The FDA product code for Active-X Total Knee System is JWH.

相關臨床試驗

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其他以 Signature Orthopaedics Pty, Ltd. 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。

K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadK253239Active-V Total Knee System; World Total Knee SystemK251771Cambridge Partial KneeK243021Longboard Revision Hip StemK242674Freedom Posterior Cervical ScrewsK242477Shoulder Soft Tissue Anchors

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相關器械（代碼：JWH）

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。

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

官方來源

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