FDA 510(k)

FIREFLY®ピードルスクリューナビゲーションガイド

K番号: K253472 · 2026-02-25

決定日2026-02-25

製品コードPQC

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

FIREFLY® Pedicle Screw Navigation Guide is the device name listed in this FDA 510(k) record. The listed applicant is Mighty Oak Medical. It received FDA 510(k) clearance on 2026-02-25 under 510(k) number K253472. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the FIREFLY® Pedicle Screw Navigation Guide?

FIREFLY® Pedicle Screw Navigation Guide is a medical device that received FDA 510(k) clearance on 2026-02-25. The listed applicant is Mighty Oak Medical. The 510(k) number is K253472.

When did FIREFLY® Pedicle Screw Navigation Guide receive FDA 510(k) clearance?

FIREFLY® Pedicle Screw Navigation Guide received FDA 510(k) clearance on 2026-02-25, under 510(k) number K253472.

Who is the listed applicant for FIREFLY® Pedicle Screw Navigation Guide?

The FDA 510(k) record lists Mighty Oak Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIREFLY® Pedicle Screw Navigation Guide?

The FDA product code for FIREFLY® Pedicle Screw Navigation Guide is PQC.

申請者としてMighty Oak Medicalを記載するその他の記録

K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

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