FDA 510(k)

TriMed 全腕融合系統（全腕融合板）

K 號：K251945 · 2025-07-10

決定日期2025-07-10

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2025-07-10 under 510(k) number K251945. 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 TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)?

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) is a medical device that received FDA 510(k) clearance on 2025-07-10. The listed applicant is TriMed, Inc.. The 510(k) number is K251945.

When did TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) receive FDA 510(k) clearance?

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) received FDA 510(k) clearance on 2025-07-10, under 510(k) number K251945.

Who is the listed applicant for TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)?

FDA 510(k) 記錄將 TriMed, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)?

The FDA product code for TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) is HRS.

其他以 TriMed, Inc. 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。

K262344大型壓縮螺釘 K262032TriMed 非跨越式手部融合板 (NSFL-STD)；TriMed 非跨越式手部融合板 (NSFR-STD)；TriMed 非跨越式手部融合板 (NSFL-SHB)；TriMed 非跨越式手部融合板 (NSFR-SHB)K261241三麗美壓縮螺釘 K254002TriMed 適應性承重板 (VBEAL-13-7S)；TriMed 適應性承重板 (VBEAR-13-7S)；TriMed 適應性承重板 (VBEAL-14-7S)；TriMed 適應性承重板 (VBEAR-14-7S)；TriMed 適應性承重板 (VBEAL-16-7S)；TriMed 適應性承重板 (VBEAR-16-7S)K252061遠端 extremities 系統 K251134RipCord

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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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