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FDA PMA

人工脊椎,棘突間隔/板

PMA 核准號:P140004 · 2024-11-07

決定日期2024-11-07
PMA 編號P140004
產品代碼NQO
器械分類3 類
醫療專科U
諮詢委員會或

器材摘要

Prosthesis, spinous process spacer/plate is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2024-11-07. 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.

常見問題

What is the Prosthesis, spinous process spacer/plate?

Prosthesis, spinous process spacer/plate is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Boston Scientific Neuromodulation.

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 Boston Scientific Neuromodulation 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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官方來源

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