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FDA 510(k)

美國米尼曼G5融合板；米尼曼G1（後融合板 /HA後融合板）；HA米尼曼G3-R MIS融合板；米尼曼G3/HA米尼曼G3

K 號：K234051 · 2024-01-18

申請人Spinal Simplicity, LLC
決定日期2024-01-18
產品代碼PEK
諮詢委員會或
決定相當於

器材摘要

Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K234051. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3?

Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K234051.

When did Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 receive FDA 510(k) clearance?

Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 received FDA 510(k) clearance on 2024-01-18, under 510(k) number K234051.

Who is the listed applicant for Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3?

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

What is the FDA product code for Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3?

The FDA product code for Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 is PEK.

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 Spinal Simplicity, 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。

K253250美國FDA認證 Minuteman® G6 MIS 融合板K250001Patriot SI 嵌入系統K240592沃夫氏法前頸椎板系統K232259Patriot-SI 背部植入系統K231923Liberty SI 横向植入系統K233527Minuteman G5 MIS融合板；Minuteman G1（後融合板 /HA後融合板）；HA Minuteman G3-R MIS融合板；Minuteman G3/HA Minuteman G3 MIS融合板

查看所有 12 項裝置 →

相關器械（代碼：PEK）

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。

K253250美國FDA認證 Minuteman® G6 MIS 融合板Spinal Simplicity, LLCK233527Minuteman G5 MIS融合板；Minuteman G1（後融合板 /HA後融合板）；HA Minuteman G3-R MIS融合板；Minuteman G3/HA Minuteman G3 MIS融合板Spinal Simplicity, LLCK232484KeyLift™ 可擴展式間層穩定系統FlospineK231807primaLOK™ SP 間棘融合系統Wenzel Spine, Inc.K223790Huvex間盤融合系統Dio Medical Corp.K221023後融合板/HA後融合板（Minuteman G1），Minuteman G3/HA Minuteman G3，HA Minuteman G3-R，Minuteman G5Spinal Simplicity, LLC

官方來源

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