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FDA 510(k)

Coalesce™（-直型、-凸型、-新月型、-側型、-前型或-斜型）腰椎間融合系統

K 號：K163506 · 2017-06-19

申請人Vertera, Inc.
決定日期2017-06-19
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Vertera, Inc.. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K163506. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System?

Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Vertera, Inc.. The 510(k) number is K163506.

When did Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System received FDA 510(k) clearance on 2017-06-19, under 510(k) number K163506.

Who is the listed applicant for Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System?

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

What is the FDA product code for Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System?

The FDA product code for Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is MAX.

相關臨床試驗

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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相關器械（代碼：MAX）

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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