頸椎間隔器
K 號：K182477 · 2019-01-28
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器材摘要
Cervical Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Additive Implants, LLC. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K182477. 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 Cervical Spacer?
Cervical Spacer is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Additive Implants, LLC. The 510(k) number is K182477.
When did Cervical Spacer receive FDA 510(k) clearance?
Cervical Spacer received FDA 510(k) clearance on 2019-01-28, under 510(k) number K182477.
Who is the listed applicant for Cervical Spacer?
The FDA 510(k) record lists Additive Implants, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cervical Spacer?
The FDA product code for Cervical Spacer is ODP.
相關臨床試驗
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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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官方來源
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