FDA 510(k)

EquivaBone 骨形成誘導性骨移植補助材（EquivaBone）

K番号: K243609 · 2024-12-18

決定日2024-12-18

製品コードMQV

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Substantially Equivalent

医療機器の概要

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corporation. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K243609. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Etex Corporation. The 510(k) number is K243609.

When did EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) receive FDA 510(k) clearance?

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) received FDA 510(k) clearance on 2024-12-18, under 510(k) number K243609.

Who is the listed applicant for EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

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

What is the FDA product code for EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

The FDA product code for EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is MQV.

申請者としてEtex Corporationを記載するその他の記録

K182107CarriGen PF

公式ソース

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