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FDA 510(k)

Epic extremity 穿刺螺釘系統

K 號：K153333 · 2016-01-19

申請人Epic Extremity, LLC
決定日期2016-01-19
產品代碼HWC
諮詢委員會或
決定相當於

器材摘要

Epic Extremity Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Epic Extremity, LLC. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K153333. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Epic Extremity Cannulated Screw System?

Epic Extremity Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Epic Extremity, LLC. The 510(k) number is K153333.

When did Epic Extremity Cannulated Screw System receive FDA 510(k) clearance?

Epic Extremity Cannulated Screw System received FDA 510(k) clearance on 2016-01-19, under 510(k) number K153333.

Who is the listed applicant for Epic Extremity Cannulated Screw System?

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

What is the FDA product code for Epic Extremity Cannulated Screw System?

The FDA product code for Epic Extremity Cannulated Screw System is HWC. This falls under the Cardiovascular category.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Epic Extremity, 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。

K182991EPIC四肢融合板系統K172441EPIC四肢骨折板系統K163038EPIC四肢快速斷開螺釘K153340Epic extremity plate 系統

相關器械（代碼：HWC）

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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