FDA 510(k)

Blustone Synergy Diamond SA 頸椎系統

K 號：K210382 · 2021-07-23

決定日期2021-07-23

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Blustone Synergy Diamond SA Cervical System is the device name listed in this FDA 510(k) record. The listed applicant is Blustone Synergy, LLC. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K210382. 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 Blustone Synergy Diamond SA Cervical System?

Blustone Synergy Diamond SA Cervical System is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Blustone Synergy, LLC. The 510(k) number is K210382.

When did Blustone Synergy Diamond SA Cervical System receive FDA 510(k) clearance?

Blustone Synergy Diamond SA Cervical System received FDA 510(k) clearance on 2021-07-23, under 510(k) number K210382.

Who is the listed applicant for Blustone Synergy Diamond SA Cervical System?

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

What is the FDA product code for Blustone Synergy Diamond SA Cervical System?

The FDA product code for Blustone Synergy Diamond SA Cervical System is OVE.

其他以 Blustone Synergy, LLC 為申請人之記錄

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K203520Blustone Synergy 間隙融合系統

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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