FDA 510(k)

SeaSpine WaveForm, C間隙系統

K 號：K213359 · 2021-12-09

決定日期2021-12-09

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

SeaSpine WaveForm, C Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2021-12-09 under 510(k) number K213359. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SeaSpine WaveForm, C Interbody System?

SeaSpine WaveForm, C Interbody System is a medical device that received FDA 510(k) clearance on 2021-12-09. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K213359.

When did SeaSpine WaveForm, C Interbody System receive FDA 510(k) clearance?

SeaSpine WaveForm, C Interbody System received FDA 510(k) clearance on 2021-12-09, under 510(k) number K213359.

Who is the listed applicant for SeaSpine WaveForm, C Interbody System?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeaSpine WaveForm, C Interbody System?

The FDA product code for SeaSpine WaveForm, C Interbody System is OVE.

其他以 SeaSpine Orthopedics Corporation 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：OVE）

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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