FDA 510(k)

prodisc® L Instruments

K番号: K250554 · 2025-04-25

決定日2025-04-25

製品コードQLQ

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

prodisc® L Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Centinel Spine, LLC. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K250554. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the prodisc® L Instruments?

prodisc® L Instruments is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Centinel Spine, LLC. The 510(k) number is K250554.

When did prodisc® L Instruments receive FDA 510(k) clearance?

prodisc® L Instruments received FDA 510(k) clearance on 2025-04-25, under 510(k) number K250554.

Who is the listed applicant for prodisc® L Instruments?

The FDA 510(k) record lists Centinel Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for prodisc® L Instruments?

The FDA product code for prodisc® L Instruments is QLQ.

申請者としてCentinel Spine, LLCを記載するその他の記録

K242869prodisc® L Instruments K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。