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FDA 510(k)

Longeviti ClearFit™ 頭蓋外用植入物

K 號：K212058 · 2021-09-08

申請人Longeviti Neuro Solutions, LLC
決定日期2021-09-08
產品代碼GXN
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

Longeviti ClearFit™ OTS Cranial Implants is the device name listed in this FDA 510(k) record. The listed applicant is Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K212058. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Longeviti ClearFit™ OTS Cranial Implants?

Longeviti ClearFit™ OTS Cranial Implants is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K212058.

When did Longeviti ClearFit™ OTS Cranial Implants receive FDA 510(k) clearance?

Longeviti ClearFit™ OTS Cranial Implants received FDA 510(k) clearance on 2021-09-08, under 510(k) number K212058.

Who is the listed applicant for Longeviti ClearFit™ OTS Cranial Implants?

The FDA 510(k) record lists Longeviti Neuro Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Longeviti ClearFit™ OTS Cranial Implants?

The FDA product code for Longeviti ClearFit™ OTS Cranial Implants is GXN.

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

其他以 Longeviti Neuro Solutions, LLC 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。

K231920Longeviti 清適型即用頭蓋植入物K211514Longeviti PorousFit 嵌入式體K210616長壽PMMA靜態頭蓋內植物K203349Longeviti 清適頭蓋植入體K202901Longeviti 清適頭蓋植入體K191210Longeviti 清適頭蓋植入體

查看所有 8 項裝置 →

相關器械（代碼：GXN）

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。

K260709ClearFit Ti Ring 14mm (171750)；ClearFit Ti Ring 14mm 內槽版 (171751)；ClearFit Ti Ring 20mm (171752)；ClearFit Ti Ring 20mm 內槽版 (171753)；ClearFit Ti Ring 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC钛颅骨板（TCP）系統The Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958謹慎個別化钛金網植入物Meticuly Co., Ltd.K243715Synthes 個體化植入物Synthes GmbHK252573KLS Martin 頭蓋內植物 - MR條件性；K944565：KLS-Martin 微骨固定系統（1.5MM）；K971297：KLS Martin 中心驅動無釘螺釘；K060177：KLS Martin 嚴格固定 - 無菌；K062570：個人化病人解決方案 - Ti（IPS-Ti）；K072707：個人化病人解決方案 - PEEK（IPS-PEEK）；K151382：個人化病人解決方案 - （IPS-PEEK）- 無菌KLS-Martin L.P.

官方來源

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