FDA 510(k)

Swedge™脊椎釘固定システムベジェールロッド

K番号: K252461 · 2026-01-13

決定日2026-01-13

製品コードNKB

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてSpinal Resources, Inc.を記載するその他の記録

K230482Swedge™脊椎釘固定システム K170045Swedge™脊椎釘固定システム K152662S-Wire

公式ソース

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