FDA 510(k)

RIVA後方固定システム；RIVA後方固定システムナビゲーション機器

K番号: K251154 · 2025-06-12

決定日2025-06-12

製品コードNKB

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

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251154. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Ht Medical D.B.A. Xenix Medical. The 510(k) number is K251154.

When did RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments receive FDA 510(k) clearance?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251154.

Who is the listed applicant for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

The FDA 510(k) record lists Ht Medical D.B.A. Xenix Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

The FDA product code for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is NKB.

申請者としてHt Medical D.B.A. Xenix Medicalを記載するその他の記録

K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical K231829Xenix Medical Sacroiliac Fixation System

公式ソース

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