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FDA 510(k)

ORION脊椎系統

K 號：K190600 · 2020-08-18

申請人Orion Biotech, Inc.
決定日期2020-08-18
產品代碼NKB
諮詢委員會或
決定相當於

器材摘要

ORION Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Orion Biotech, Inc.. It received FDA 510(k) clearance on 2020-08-18 under 510(k) number K190600. 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 ORION Spinal System?

ORION Spinal System is a medical device that received FDA 510(k) clearance on 2020-08-18. The listed applicant is Orion Biotech, Inc.. The 510(k) number is K190600.

When did ORION Spinal System receive FDA 510(k) clearance?

ORION Spinal System received FDA 510(k) clearance on 2020-08-18, under 510(k) number K190600.

Who is the listed applicant for ORION Spinal System?

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

What is the FDA product code for ORION Spinal System?

The FDA product code for ORION Spinal System is NKB.

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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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官方來源

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