FDA 510(k)

生物多全趾半關節成形術植入體

K 號：K203634 · 2021-02-02

決定日期2021-02-02

產品代碼KWD

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器材摘要

BioPoly Great Toe Hemiarthroplasty Implant is the device name listed in this FDA 510(k) record. The listed applicant is BioPoly, LLC. It received FDA 510(k) clearance on 2021-02-02 under 510(k) number K203634. 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 BioPoly Great Toe Hemiarthroplasty Implant?

BioPoly Great Toe Hemiarthroplasty Implant is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is BioPoly, LLC. The 510(k) number is K203634.

When did BioPoly Great Toe Hemiarthroplasty Implant receive FDA 510(k) clearance?

BioPoly Great Toe Hemiarthroplasty Implant received FDA 510(k) clearance on 2021-02-02, under 510(k) number K203634.

Who is the listed applicant for BioPoly Great Toe Hemiarthroplasty Implant?

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

What is the FDA product code for BioPoly Great Toe Hemiarthroplasty Implant?

The FDA product code for BioPoly Great Toe Hemiarthroplasty Implant is KWD.

其他以 BioPoly, LLC 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。

K233592生物多向頭顱植入體 K222964生物多樂小趾半關節成形術植入體

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.K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.

官方來源

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