FDA 510(k)

Ascension矽膠MCP; Ascension矽膠PIP

K 號：K233670 · 2023-12-14

決定日期2023-12-14

產品代碼KYJ

諮詢委員會或

決定相當於

器材摘要

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.

常見問題

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.

其他以 Ascension Orthopedics, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K233674自由手腕關節成形系統

相關器械（代碼：KYJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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