FDA 510(k)

Proficient® 頸椎後部脊柱系統

K 號：K172594 · 2017-12-15

決定日期2017-12-15

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Proficient® Posterior Cervical Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172594. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Proficient® Posterior Cervical Spine System?

Proficient® Posterior Cervical Spine System is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Spine Wave, Inc.. The 510(k) number is K172594.

When did Proficient® Posterior Cervical Spine System receive FDA 510(k) clearance?

Proficient® Posterior Cervical Spine System received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172594.

Who is the listed applicant for Proficient® Posterior Cervical Spine System?

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

What is the FDA product code for Proficient® Posterior Cervical Spine System?

The FDA product code for Proficient® Posterior Cervical Spine System is NKG.

其他以 Spine Wave, Inc. 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。

K260286Dynamo™脊椎水泥；Salvo®脊椎系統 K261159Exceed®雙平面擴張式椎間融合系統 K243816Testa TP 旋轉間隔系統 K251131Annex® 2 邻近層級系統 K243514Salvo®機器人導航儀器 K240685Salvo®脊椎系統

查看所有 24 項裝置 →

相關器械（代碼：NKG）

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。

K254260VEGA 子宮頸螺釘系統GS Medical Co., Ltd.K253195泰魯斯後枕顱頸胸脊椎系統ZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® 頸椎後路螺釘系統；CarboClear® 混合後路螺釘系統CarboFix Orthopedics , Ltd.K254165Infinity™ 光學斷層掃描系統Medtronic Sofamor Danek USA, Inc.K252327CMORE® CT系統；CMORE® CT系統導航儀器Icotec AG K253129Infinity™ 光學斷層掃描系統Medtronic Sofamor Danek USA, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。