FDA 510(k)

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K 號：K232267 · 2023-12-15

申請人Nuvasive Specialized Orthopedics, Incorporated

決定日期2023-12-15

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Precice Max System is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Incorporated. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232267. 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 Max System?

Precice Max System is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Nuvasive Specialized Orthopedics, Incorporated. The 510(k) number is K232267.

When did Precice Max System receive FDA 510(k) clearance?

Precice Max System received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232267.

Who is the listed applicant for Precice Max System?

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

What is the FDA product code for Precice Max System?

The FDA product code for Precice Max System is HSB.

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