FDA 510(k)

Hive™ 独立式頸椎系統

K 號：K223190 · 2022-12-12

決定日期2022-12-12

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Hive™ Standalone Cervical System is the device name listed in this FDA 510(k) record. The listed applicant is NanoHive Medical, LLC. It received FDA 510(k) clearance on 2022-12-12 under 510(k) number K223190. 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 Hive™ Standalone Cervical System?

Hive™ Standalone Cervical System is a medical device that received FDA 510(k) clearance on 2022-12-12. The listed applicant is NanoHive Medical, LLC. The 510(k) number is K223190.

When did Hive™ Standalone Cervical System receive FDA 510(k) clearance?

Hive™ Standalone Cervical System received FDA 510(k) clearance on 2022-12-12, under 510(k) number K223190.

Who is the listed applicant for Hive™ Standalone Cervical System?

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

What is the FDA product code for Hive™ Standalone Cervical System?

The FDA product code for Hive™ Standalone Cervical System is OVE.

其他以 NanoHive Medical, LLC 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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官方來源

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