FDA 510(k)

RipCord

K 號：K251134 · 2025-07-11

決定日期2025-07-11

產品代碼HTN

諮詢委員會或

決定相當於

器材摘要

RipCord is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K251134. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RipCord?

RipCord is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is TriMed, Inc.. The 510(k) number is K251134.

When did RipCord receive FDA 510(k) clearance?

RipCord received FDA 510(k) clearance on 2025-07-11, under 510(k) number K251134.

Who is the listed applicant for RipCord?

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 RipCord?

The FDA product code for RipCord is HTN.

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 K251945TriMed 全腕融合系統（全腕融合板）

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相關器械（代碼：HTN）

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。

K253115LARS ACJMovmedix S.A.S.K252081運動連結關節固定器Lincotek Medical K253727關節固定緊繩PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K243624Acu-Sinch Knotless MiniAcumed, LLC K242091博洛按鈕系統Fusion Orthopedics

官方來源

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