FDA 510(k)

Invictus® 矮身材脊椎固定系統

K 號：K241519 · 2024-06-21

決定日期2024-06-21

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Invictus® Small Stature Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K241519. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Invictus® Small Stature Spinal Fixation System?

Invictus® Small Stature Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K241519.

When did Invictus® Small Stature Spinal Fixation System receive FDA 510(k) clearance?

Invictus® Small Stature Spinal Fixation System received FDA 510(k) clearance on 2024-06-21, under 510(k) number K241519.

Who is the listed applicant for Invictus® Small Stature Spinal Fixation System?

FDA 510(k) 記錄將 Alphatec 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 Invictus® Small Stature Spinal Fixation System?

The FDA product code for Invictus® Small Stature Spinal Fixation System is NKB.

其他以 Alphatec Spine, Inc. 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。

K261284Invictus® 小身材脊椎固定系統；Invictus® 2.0 脊椎固定系統 K253216內科手術對齊系統；CONTOUR3D 弯曲系統 K253615無敵帶系統 K252597Valence機器人導航系統；Valence機器人導航儀器（與StealthStation共用）K252842SafeOp 3：神經資訊系統 K251965近端前頸板系統；節段性板金系統（SPS）

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相關器械（代碼：NKB）

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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官方來源

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