FDA 510(k)

三角HA獨立楔形固定系統

K 號：K203445 · 2020-12-21

申請人Nvision Biomedical Technologies, Inc.

決定日期2020-12-21

產品代碼PLF

諮詢委員會或

決定相當於

器材摘要

Trigon HA Stand-Alone Wedge Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2020-12-21 under 510(k) number K203445. 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 HA Stand-Alone Wedge Fixation System?

Trigon HA Stand-Alone Wedge Fixation System is a medical device that received FDA 510(k) clearance on 2020-12-21. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K203445.

When did Trigon HA Stand-Alone Wedge Fixation System receive FDA 510(k) clearance?

Trigon HA Stand-Alone Wedge Fixation System received FDA 510(k) clearance on 2020-12-21, under 510(k) number K203445.

Who is the listed applicant for Trigon HA Stand-Alone Wedge Fixation System?

The FDA 510(k) record lists Nvision Biomedical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trigon HA Stand-Alone Wedge Fixation System?

The FDA product code for Trigon HA Stand-Alone Wedge Fixation System is PLF.

其他以 Nvision Biomedical Technologies, Inc. 為申請人之記錄

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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.K243231三角PEEK HA楔子Nvision Biomedical Technologies K234116Trigon Trigon HA 独立楔形固定系統Nvision Biomedical Technologies

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