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FDA 510(k)

CARE品牌鎖定骨板及螺釘骨合術板釘系統，CARE品牌DHS/DCS板釘系統

K 號：K153374 · 2016-06-17

申請人Orthocare
決定日期2016-06-17
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Orthocare. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K153374. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System?

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Orthocare. The 510(k) number is K153374.

When did CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System receive FDA 510(k) clearance?

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System received FDA 510(k) clearance on 2016-06-17, under 510(k) number K153374.

Who is the listed applicant for CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System?

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

What is the FDA product code for CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System?

The FDA product code for CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System is HRS.

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

相關器械（代碼：HRS）

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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