FDA 510(k)

VerteFIT脊椎切除籠架系統

K 號：K162133 · 2017-05-16

決定日期2017-05-16

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

VerteFIT Corpectomy Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K162133. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VerteFIT Corpectomy Cage System?

VerteFIT Corpectomy Cage System is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K162133.

When did VerteFIT Corpectomy Cage System receive FDA 510(k) clearance?

VerteFIT Corpectomy Cage System received FDA 510(k) clearance on 2017-05-16, under 510(k) number K162133.

Who is the listed applicant for VerteFIT Corpectomy Cage System?

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

What is the FDA product code for VerteFIT Corpectomy Cage System?

The FDA product code for VerteFIT Corpectomy Cage System is MQP.

其他以 Ldr Spine USA, 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。

K161173Avenue® T TLIF 籠 K161798FacetBRIDGE® 系統

相關器械（代碼：MQP）

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。

K261810維蒂威奇® 骨內系統Foundation Surgical Group K261031波塞冬STSignus Medinzintechnik GmbH K253158VyBrate™ VBR 系統Vy Spine, LLC K241468維蒂威奇® 骨內系統Foundation Surgical Group, Inc.K232790KONG®-TL VBR 系統及 KONG® C VBR 系統Icotec AG K233359DOMINION可擴展椎體切除系統Astura Medical

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