FDA 510(k)

CATAMARAN™ 関節融合システム

K番号: K260477 · 2026-04-08

決定日2026-04-08

製品コードOUR

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

CATAMARAN™ SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Tenon Medical. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K260477. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CATAMARAN™ SI Joint Fusion System?

CATAMARAN™ SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Tenon Medical. The 510(k) number is K260477.

When did CATAMARAN™ SI Joint Fusion System receive FDA 510(k) clearance?

CATAMARAN™ SI Joint Fusion System received FDA 510(k) clearance on 2026-04-08, under 510(k) number K260477.

Who is the listed applicant for CATAMARAN™ SI Joint Fusion System?

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

What is the FDA product code for CATAMARAN™ SI Joint Fusion System?

The FDA product code for CATAMARAN™ SI Joint Fusion System is OUR.

申請者としてTenon Medicalを記載するその他の記録

K250403カタラマランＳＩ関節融合システム

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