FDA 510(k)

MATRIX HA PEEK 頸椎 IBF 系統

K 號：K232619 · 2024-03-19

決定日期2024-03-19

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

MATRIX HA PEEK Cervical IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Sapphire Medical Group. It received FDA 510(k) clearance on 2024-03-19 under 510(k) number K232619. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MATRIX HA PEEK Cervical IBF System?

MATRIX HA PEEK Cervical IBF System is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Sapphire Medical Group. The 510(k) number is K232619.

When did MATRIX HA PEEK Cervical IBF System receive FDA 510(k) clearance?

MATRIX HA PEEK Cervical IBF System received FDA 510(k) clearance on 2024-03-19, under 510(k) number K232619.

Who is the listed applicant for MATRIX HA PEEK Cervical IBF System?

The FDA 510(k) record lists Sapphire Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MATRIX HA PEEK Cervical IBF System?

The FDA product code for MATRIX HA PEEK Cervical IBF System is ODP.

其他以 Sapphire Medical Group 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。

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相關器械（代碼：ODP）

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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