FDA 510(k)

精準® 螺釘

K 號：K193617 · 2020-05-08

申請人Nuvasive Specialized Orthopedics, Inc.

決定日期2020-05-08

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Precice® Screws is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-05-08 under 510(k) number K193617. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Precice® Screws?

Precice® Screws is a medical device that received FDA 510(k) clearance on 2020-05-08. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K193617.

When did Precice® Screws receive FDA 510(k) clearance?

Precice® Screws received FDA 510(k) clearance on 2020-05-08, under 510(k) number K193617.

Who is the listed applicant for Precice® Screws?

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

What is the FDA product code for Precice® Screws?

The FDA product code for Precice® Screws is HSB.

其他以 Nuvasive Specialized Orthopedics, Inc. 為申請人之記錄

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相關器械（代碼：HSB）

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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