FDA 510(k)

MAGEC脊椎支具及擴張系統

K 號：K233593 · 2024-02-06

申請人Nuvasive Specialized Orthopedics, Incorporated

決定日期2024-02-06

產品代碼PGN

諮詢委員會或

決定相當於

器材摘要

MAGEC Spinal Bracing and Distraction 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 2024-02-06 under 510(k) number K233593. The device is classified under product code PGN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MAGEC Spinal Bracing and Distraction System?

MAGEC Spinal Bracing and Distraction System is a medical device that received FDA 510(k) clearance on 2024-02-06. The listed applicant is Nuvasive Specialized Orthopedics, Incorporated. The 510(k) number is K233593.

When did MAGEC Spinal Bracing and Distraction System receive FDA 510(k) clearance?

MAGEC Spinal Bracing and Distraction System received FDA 510(k) clearance on 2024-02-06, under 510(k) number K233593.

Who is the listed applicant for MAGEC Spinal Bracing and Distraction 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 MAGEC Spinal Bracing and Distraction System?

The FDA product code for MAGEC Spinal Bracing and Distraction System is PGN.

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

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。

K232267精準麥克斯系統 K171791MAGEC®系統 K170939補充儀器盤

相關器械（代碼：PGN）

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。

K201543MAGEC®系統Nuvasive Specialized Orthopedics, Inc.K171791MAGEC®系統Nuvasive Specialized Orthopedics, Incorporated K160352MAGEC®脊椎支具及擴張系統Nuvasive Specialized Orthopedics, Inc.K161751MAGEC®脊椎支具及擴張系統Nuvasive Specialized Orthopedics, Inc.

官方來源

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