脊椎釘系統
K 號：K201751 · 2020-07-22
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器材摘要
Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Black Box Medical, LLC. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K201751. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Pedicle Screw System?
Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Black Box Medical, LLC. The 510(k) number is K201751.
When did Pedicle Screw System receive FDA 510(k) clearance?
Pedicle Screw System received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201751.
Who is the listed applicant for Pedicle Screw System?
The FDA 510(k) record lists Black Box Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pedicle Screw System?
The FDA product code for Pedicle Screw System is NKB.
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相關 PubMed 文獻
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相關器械（代碼：NKB）
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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