FDA 510(k)

UHR雙極植入體，Restoration GAP II 植入體

K 號：K222632 · 2022-10-21

申請人Howmedica Osteonics Corp., Dba Stryker Orthopaedics

決定日期2022-10-21

產品代碼KWL

諮詢委員會或

決定相當於

器材摘要

UHR Bipolar Implants, Restoration GAP II Implants is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K222632. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UHR Bipolar Implants, Restoration GAP II Implants?

UHR Bipolar Implants, Restoration GAP II Implants is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K222632.

When did UHR Bipolar Implants, Restoration GAP II Implants receive FDA 510(k) clearance?

UHR Bipolar Implants, Restoration GAP II Implants received FDA 510(k) clearance on 2022-10-21, under 510(k) number K222632.

Who is the listed applicant for UHR Bipolar Implants, Restoration GAP II Implants?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UHR Bipolar Implants, Restoration GAP II Implants?

The FDA product code for UHR Bipolar Implants, Restoration GAP II Implants is KWL.

其他以 Howmedica Osteonics Corp., Dba Stryker Orthopaedics 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。

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相關器械（代碼：KWL）

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。

K262290REMEDY POLY+PLUS 快速適合髋白杯Osteoremedies, LLC K260536Prostalac 髋關節系統，SmartSet V+G雙抗生素骨水泥Depuy Ireland UC K253675骨修療股骨間隙系統Osteoremedies, LLC K252326InterSpace GV 髋關節間隔器Tecres S.P.A.K242865Synicem 髋關節間隔器；Synicem 開節間隔器；Synicem 肩關節間隔器Biocomposites, Ltd.K234028COPAL®交換G股間隔器；COPAL®G+VHeraeus Medical GmbH

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