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FDA 510(k)

coftex-IF

K 號：K153302 · 2016-09-08

申請人Paradigm Spine, LLC
決定日期2016-09-08
產品代碼PEK
諮詢委員會或
決定相當於

器材摘要

coflex-IF is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Spine, LLC. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K153302. 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 coflex-IF?

coflex-IF is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Paradigm Spine, LLC. The 510(k) number is K153302.

When did coflex-IF receive FDA 510(k) clearance?

coflex-IF received FDA 510(k) clearance on 2016-09-08, under 510(k) number K153302.

Who is the listed applicant for coflex-IF?

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

What is the FDA product code for coflex-IF?

The FDA product code for coflex-IF 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

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, LLCK234051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G3Spinal 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.

官方來源

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