FDA 510(k)

三角PEEK HA楔子

K 號：K243231 · 2024-11-08

決定日期2024-11-08

產品代碼PLF

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器材摘要

Trigon PEEK HA Wedges is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K243231. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Trigon PEEK HA Wedges?

Trigon PEEK HA Wedges is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Nvision Biomedical Technologies. The 510(k) number is K243231.

When did Trigon PEEK HA Wedges receive FDA 510(k) clearance?

Trigon PEEK HA Wedges received FDA 510(k) clearance on 2024-11-08, under 510(k) number K243231.

Who is the listed applicant for Trigon PEEK HA Wedges?

FDA 510(k) 記錄將 Nvision Biomedical Technologies 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Trigon PEEK HA Wedges?

The FDA product code for Trigon PEEK HA Wedges is PLF.

其他以 Nvision Biomedical Technologies 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。

K262098EnHAnce PEEK 趾骨隆起系統 K250646影響 PEEK 聯合釘系統 K242896Caliber 髓內固定系統 K234116Trigon Trigon HA 独立楔形固定系統

相關器械（代碼：PLF）

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。

K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC K252254骨切楔形系統Sinaptic Surgical K251791Auxano® 極板固定系統Auxano Medical, LLC K240461OsteoSinter® EVANS 與 COTTON 塊及相關配件Ames Medical Prosthetic Solutions, S.A.U.K234116Trigon Trigon HA 独立楔形固定系統Nvision Biomedical Technologies K231496TITAN 3-D 角楔系統Paragon 28, Inc.

官方來源

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