FDA 510(k)

大腿再建内固定釘システム、大腿後退内固定釘システム、上腕骨内固定釘システム、胫骨内固定釘システム、圧縮臀部釘システム

K番号: K230071 · 2024-08-22

決定日2024-08-22

製品コードHSB

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

Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Tdm Co., Ltd.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K230071. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System?

Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K230071.

When did Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System receive FDA 510(k) clearance?

Who is the listed applicant for Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System?

The FDA 510(k) record lists Tdm Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System?

The FDA product code for Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System is HSB.