FDA 510(k)

Genesys脊椎骨盆關節融合系統

K 號：K191748 · 2019-09-26

決定日期2019-09-26

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

Genesys Spine Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K191748. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Genesys Spine Sacroiliac Joint Fusion System?

Genesys Spine Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Genesys Spine. The 510(k) number is K191748.

When did Genesys Spine Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

Genesys Spine Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2019-09-26, under 510(k) number K191748.

Who is the listed applicant for Genesys Spine Sacroiliac Joint Fusion System?

The FDA 510(k) record lists Genesys Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genesys Spine Sacroiliac Joint Fusion System?

The FDA product code for Genesys Spine Sacroiliac Joint Fusion System is OUR.

其他以 Genesys Spine 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。

K252322西羅斯-X系統 K242483Genesys脊椎AIS-C II頸椎間融合系統 K233595Genesys脊椎骨盆關節融合系統配導航 K233594Genesys Spine 3DP AIS-C II 頸椎間盤系統 K220096Genesys Spine 3DP 腰椎間盤系統 K191489Genesys脊椎3DP頸椎間盤系統

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相關器械（代碼：OUR）

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。

K261381TiLink-L™ 骨盆聯合融合系統SurGenTec, LLC K260477CATAMARAN™ 骨盆聯合融合系統Tenon Medical K253488iFuse INTRA Ti™ 嵌入系統SI-BONE, Inc.K253611鷹融合系統Mcnicoll Surgical, Inc.K252834骨盆釘合系統 (SJTS)4Web Medical K251365OptumSI 嵌入式系統Si Solutions, LLC

官方來源

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