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FDA 510(k)

ArtFx 胸椎切除籠架（Espinax 和 Distractania 胸椎切除籠架）

K 號：K211892 · 2022-10-06

申請人Arftx Medical, LLC
決定日期2022-10-06
產品代碼MQP
諮詢委員會或
決定相當於

器材摘要

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is the device name listed in this FDA 510(k) record. The listed applicant is Arftx Medical, LLC. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K211892. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Arftx Medical, LLC. The 510(k) number is K211892.

When did ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) receive FDA 510(k) clearance?

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) received FDA 510(k) clearance on 2022-10-06, under 510(k) number K211892.

Who is the listed applicant for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

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

What is the FDA product code for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

The FDA product code for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is MQP.

相關臨床試驗

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：MQP）

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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