FDA 510(k)

primaLOK™ SP 間棘融合系統

K 號：K231807 · 2023-08-15

決定日期2023-08-15

產品代碼PEK

諮詢委員會或

決定相當於

器材摘要

primaLOK™ SP Interspinous Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Wenzel Spine, Inc.. It received FDA 510(k) clearance on 2023-08-15 under 510(k) number K231807. 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 primaLOK™ SP Interspinous Fusion System?

primaLOK™ SP Interspinous Fusion System is a medical device that received FDA 510(k) clearance on 2023-08-15. The listed applicant is Wenzel Spine, Inc.. The 510(k) number is K231807.

When did primaLOK™ SP Interspinous Fusion System receive FDA 510(k) clearance?

primaLOK™ SP Interspinous Fusion System received FDA 510(k) clearance on 2023-08-15, under 510(k) number K231807.

Who is the listed applicant for primaLOK™ SP Interspinous Fusion System?

FDA 510(k) 記錄將 Wenzel Spine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for primaLOK™ SP Interspinous Fusion System?

The FDA product code for primaLOK™ SP Interspinous Fusion System is PEK.

其他以 Wenzel Spine, Inc. 為申請人之記錄

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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。

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