FDA 510(k)

C-VBR

K 號：K152568 · 2016-02-11

決定日期2016-02-11

產品代碼PLR

諮詢委員會或

決定相當於

器材摘要

C-VBR is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Spine, LLC. It received FDA 510(k) clearance on 2016-02-11 under 510(k) number K152568. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the C-VBR?

C-VBR is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Cardinal Spine, LLC. The 510(k) number is K152568.

When did C-VBR receive FDA 510(k) clearance?

C-VBR received FDA 510(k) clearance on 2016-02-11, under 510(k) number K152568.

Who is the listed applicant for C-VBR?

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

What is the FDA product code for C-VBR?

The FDA product code for C-VBR is PLR.

相關器械（代碼：PLR）

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。

K252822Atlas脊椎HiRISE™可擴展頸椎前柱切除植入體Atlas Spine, Inc.K252560Atlas Spine HiRISE™ 可擴張頸椎椎體切除系統Atlas Spine, Inc.K232481RIGEL™ 3DR 頸部前方椎體切除系統MiRus, LLC K221542伽利略脊椎體置換設備Bright Spine K212126MediExpand 頸部擴張式VBR系統Cmf Medicon Surgical, Inc.K211320CAPRI 胸椎切除籠架系統K2m, Inc.

官方來源

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