FDA 510(k)

Swedge™脊椎螺釘固定系統貝茲爾桿

K 號：K252461 · 2026-01-13

決定日期2026-01-13

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Swedge™ Pedicle Screw Fixation System Bezier Rod is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Resources, Inc.. It received FDA 510(k) clearance on 2026-01-13 under 510(k) number K252461. 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 Swedge™ Pedicle Screw Fixation System Bezier Rod?

Swedge™ Pedicle Screw Fixation System Bezier Rod is a medical device that received FDA 510(k) clearance on 2026-01-13. The listed applicant is Spinal Resources, Inc.. The 510(k) number is K252461.

When did Swedge™ Pedicle Screw Fixation System Bezier Rod receive FDA 510(k) clearance?

Swedge™ Pedicle Screw Fixation System Bezier Rod received FDA 510(k) clearance on 2026-01-13, under 510(k) number K252461.

Who is the listed applicant for Swedge™ Pedicle Screw Fixation System Bezier Rod?

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

What is the FDA product code for Swedge™ Pedicle Screw Fixation System Bezier Rod?

The FDA product code for Swedge™ Pedicle Screw Fixation System Bezier Rod is NKB.

其他以 Spinal Resources, 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。

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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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