FDA 510(k)

Accu-Joint Hemi Implant

K 號：K200951 · 2020-12-08

決定日期2020-12-08

產品代碼KWD

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決定相當於

器材摘要

Accu-Joint Hemi Implant is the device name listed in this FDA 510(k) record. The listed applicant is Accufix Surgical, Inc.. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K200951. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Accu-Joint Hemi Implant?

Accu-Joint Hemi Implant is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Accufix Surgical, Inc.. The 510(k) number is K200951.

When did Accu-Joint Hemi Implant receive FDA 510(k) clearance?

Accu-Joint Hemi Implant received FDA 510(k) clearance on 2020-12-08, under 510(k) number K200951.

Who is the listed applicant for Accu-Joint Hemi Implant?

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

What is the FDA product code for Accu-Joint Hemi Implant?

The FDA product code for Accu-Joint Hemi Implant is KWD.

其他以 Accufix Surgical, 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。

K240268Accu-Joint Hemi Implant

相關器械（代碼：KWD）

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。

K250074HYALEX® MTP 半關節成形術植入體Hyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220蒙羅斯 extremity 医療半植入系統Montross Extremity Medical K222964生物多樂小趾半關節成形術植入體BioPoly, LLC K201393restor3d MTP植入體Restor3D, Inc.K203634生物多全趾半關節成形術植入體BioPoly, LLC

官方來源

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