FDA 510(k)

Genesys Spine 3DP 腰椎間盤系統

K 號：K182987 · 2019-12-12

決定日期2019-12-12

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Genesys Spine 3DP Lumbar Interbody 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 2019-12-12 under 510(k) number K182987. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Genesys Spine 3DP Lumbar Interbody System?

Genesys Spine 3DP Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2019-12-12. The listed applicant is Genesys Spine. The 510(k) number is K182987.

When did Genesys Spine 3DP Lumbar Interbody System receive FDA 510(k) clearance?

Genesys Spine 3DP Lumbar Interbody System received FDA 510(k) clearance on 2019-12-12, under 510(k) number K182987.

Who is the listed applicant for Genesys Spine 3DP Lumbar Interbody 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 3DP Lumbar Interbody System?

The FDA product code for Genesys Spine 3DP Lumbar Interbody System is MAX.

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：MAX）

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。

K261049SCALA® TLSpineart SA K261430TruLift可擴展系統Life Spine, Inc.K253011Catalyft PL 可擴展椎間體系統Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L脊椎系統Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

官方來源

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