FDA 510(k)

ShurFit 2C 腰椎間融合系統

K 號：K171657 · 2017-08-11

決定日期2017-08-11

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

ShurFit 2C Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K171657. 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 ShurFit 2C Lumbar Interbody Fusion System?

ShurFit 2C Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Precision Spine, Inc.. The 510(k) number is K171657.

When did ShurFit 2C Lumbar Interbody Fusion System receive FDA 510(k) clearance?

ShurFit 2C Lumbar Interbody Fusion System received FDA 510(k) clearance on 2017-08-11, under 510(k) number K171657.

Who is the listed applicant for ShurFit 2C Lumbar Interbody Fusion System?

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

What is the FDA product code for ShurFit 2C Lumbar Interbody Fusion System?

The FDA product code for ShurFit 2C Lumbar Interbody Fusion System is MAX.

其他以 Precision Spine, Inc. 為申請人之記錄

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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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