FDA 510(k)

頭蓋 LOOP，頭蓋 LOOP L 和頭蓋 LOOP XL 頭蓋骨固定系統

K 號：K240137 · 2024-02-16

決定日期2024-02-16

產品代碼GXR

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

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Neos Surgery S.L. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K240137. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Neos Surgery S.L. The 510(k) number is K240137.

When did Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System receive FDA 510(k) clearance?

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System received FDA 510(k) clearance on 2024-02-16, under 510(k) number K240137.

Who is the listed applicant for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

The FDA 510(k) record lists Neos Surgery S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

The FDA product code for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is GXR.

其他以 Neos Surgery S.L 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。

K221795STERN FIX 胸骨固定系統 K211613Stern Fix 胸骨固定系統 K160739頭部蓋

相關器械（代碼：GXR）

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。

K253447Montage 流動式可調節，可吸收骨膠（噴孔蓋）Orthocon, Inc.K221606可吸收頭蓋骨瓣固定系統Chendu Medart Medical Scientific Co., Ltd.K192310翻開固定器，骨孔蓋Ossaware Biotech Co., Ltd.K192162神經頻率調節颅骨固定系統，NuCrani 板，KTC 髙溝蓋，DC 板Neurovention, LLC K181539OSSDSIGN 頭蓋骨接合器Ossdsign AB K181382守護者™ 體外孔蓋系統St Jude Medical

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。