FDA 510(k)

後融合板，HA後融合板

K 號：K200066 · 2020-12-10

決定日期2020-12-10

產品代碼PEK

諮詢委員會或

決定相當於

器材摘要

Posterior Fusion Plate, HA Posterior Fusion Plate 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 2020-12-10 under 510(k) number K200066. 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 Posterior Fusion Plate, HA Posterior Fusion Plate?

Posterior Fusion Plate, HA Posterior Fusion Plate is a medical device that received FDA 510(k) clearance on 2020-12-10. The listed applicant is Spinal Simplicity, LLC. The 510(k) number is K200066.

When did Posterior Fusion Plate, HA Posterior Fusion Plate receive FDA 510(k) clearance?

Posterior Fusion Plate, HA Posterior Fusion Plate received FDA 510(k) clearance on 2020-12-10, under 510(k) number K200066.

Who is the listed applicant for Posterior Fusion Plate, HA Posterior Fusion Plate?

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 Posterior Fusion Plate, HA Posterior Fusion Plate?

The FDA product code for Posterior Fusion Plate, HA Posterior Fusion Plate is PEK.

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。

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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, LLC K234051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, LLC 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Spinal Simplicity, LLC K232484KeyLift™ 可擴展式間層穩定系統Flospine K231807primaLOK™ 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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