FDA 510(k)

AscensionシリコンMCP；AscensionシリコンPIP

K番号: K233670 · 2023-12-14

決定日2023-12-14

製品コードKYJ

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

Ascension Silicone MCP; Ascension Silicone PIP is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K233670. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Ascension Silicone MCP; Ascension Silicone PIP?

Ascension Silicone MCP; Ascension Silicone PIP is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K233670.

When did Ascension Silicone MCP; Ascension Silicone PIP receive FDA 510(k) clearance?

Ascension Silicone MCP; Ascension Silicone PIP received FDA 510(k) clearance on 2023-12-14, under 510(k) number K233670.

Who is the listed applicant for Ascension Silicone MCP; Ascension Silicone PIP?

The FDA 510(k) record lists Ascension Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ascension Silicone MCP; Ascension Silicone PIP?

The FDA product code for Ascension Silicone MCP; Ascension Silicone PIP is KYJ.

申請者としてAscension Orthopedics, Inc.を記載するその他の記録

K233674Freedom腕関節形成システム

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