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FDA 510(k)

內固定融合（IBF）/椎體置換（VBR）系統

K 號：K170643 · 2017-04-14

申請人Rti Surgical, Inc. Dba Rti Biologics
決定日期2017-04-14
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc. Dba Rti Biologics. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K170643. 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 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Rti Surgical, Inc. Dba Rti Biologics. The 510(k) number is K170643.

When did Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System receive FDA 510(k) clearance?

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System received FDA 510(k) clearance on 2017-04-14, under 510(k) number K170643.

Who is the listed applicant for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

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

What is the FDA product code for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System?

The FDA product code for Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) 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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