FDA PMA

人工脊椎、棘突間隔/プレート

PMA番号：P240043 · 2026-04-01

申請者Companion Spine France Sas

決定日2026-04-01

PMA番号P240043

製品コードNQO

デバイスクラスクラス3

診療科U

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。

医療機器の概要

Prosthesis, spinous process spacer/plate is the device name listed in this FDA 510(k) record. The listed applicant is Companion Spine France Sas. It received FDA 510(k) clearance on 2026-04-01. The device is classified under product code NQO. It was reviewed by the OR advisory panel. Product code NQO falls under the category of General Hospital, which covers general-purpose hospital equipment and supplies. Devices in this category are subject to specific FDA regulatory requirements.

よくある質問

What is the Prosthesis, spinous process spacer/plate?

Prosthesis, spinous process spacer/plate is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Companion Spine France Sas.

When did Prosthesis, spinous process spacer/plate receive FDA 510(k) clearance?

The clearance date for Prosthesis, spinous process spacer/plate can be found in the official FDA records.

Who is the listed applicant for Prosthesis, spinous process spacer/plate?

The FDA 510(k) record lists Companion Spine France Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prosthesis, spinous process spacer/plate?

The FDA product code for Prosthesis, spinous process spacer/plate is NQO. This falls under the General Hospital category.

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医療機器の概要

よくある質問

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