FDA 510(k)

SAGICO OSI脊椎系統，由Osimplant製造

K 號：K180220 · 2018-05-21

申請人Spinal Analytics & Geometrical Implant Co, LLC

決定日期2018-05-21

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

SAGICO OSI Spinal System by Osimplant is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Analytics & Geometrical Implant Co, LLC. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K180220. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SAGICO OSI Spinal System by Osimplant?

SAGICO OSI Spinal System by Osimplant is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Spinal Analytics & Geometrical Implant Co, LLC. The 510(k) number is K180220.

When did SAGICO OSI Spinal System by Osimplant receive FDA 510(k) clearance?

SAGICO OSI Spinal System by Osimplant received FDA 510(k) clearance on 2018-05-21, under 510(k) number K180220.

Who is the listed applicant for SAGICO OSI Spinal System by Osimplant?

The FDA 510(k) record lists Spinal Analytics & Geometrical Implant Co, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAGICO OSI Spinal System by Osimplant?

The FDA product code for SAGICO OSI Spinal System by Osimplant is NKB.

其他以 Spinal Analytics & Geometrical Implant Co, LLC 為申請人之記錄

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相關器械（代碼：NKB）

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。

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