FDA 510(k)

Alians 腕関節ロッキングプレートシステム

K番号: K171372 · 2018-01-04

決定日2018-01-04

製品コードHRS

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

Alians Elbow Locking Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171372. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Alians Elbow Locking Plating System?

Alians Elbow Locking Plating System is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Newclip Technics. The 510(k) number is K171372.

When did Alians Elbow Locking Plating System receive FDA 510(k) clearance?

Alians Elbow Locking Plating System received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171372.

Who is the listed applicant for Alians Elbow Locking Plating System?

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

What is the FDA product code for Alians Elbow Locking Plating System?

The FDA product code for Alians Elbow Locking Plating System is HRS.

申請者としてNewclip Technicsを記載するその他の記録

K261511Xpert Ankle K261191Alians Elbow S K261038Xpert PFP K253906Xpert Hand K250767Newclip 患者対応機器非無菌 PSI K250155Xpert Knee

すべての26件のデバイスを表示 →

公式ソース

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