FDA 510(k)

バランスド・キー・システム・トリマックス・ポアサス・フェマル・コンポーネンツ

K番号: K253161 · 2025-12-19

決定日2025-12-19

製品コードMBH

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

Balanced Knee System TriMax Porous Femoral Components is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253161. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Balanced Knee System TriMax Porous Femoral Components?

Balanced Knee System TriMax Porous Femoral Components is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Ortho Development Corp.. The 510(k) number is K253161.

When did Balanced Knee System TriMax Porous Femoral Components receive FDA 510(k) clearance?

Balanced Knee System TriMax Porous Femoral Components received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253161.

Who is the listed applicant for Balanced Knee System TriMax Porous Femoral Components?

The FDA 510(k) record lists Ortho Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Balanced Knee System TriMax Porous Femoral Components?

The FDA product code for Balanced Knee System TriMax Porous Femoral Components is MBH.

申請者としてOrtho Development Corp.を記載するその他の記録

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公式ソース

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