FDA 510(k)

Ignite無柄解剖肩部系統

K 號：K203108 · 2021-07-16

決定日期2021-07-16

產品代碼PKC

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決定相當於

器材摘要

Ignite Stemless Anatomic Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Ignite Orthopedics, LLC. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K203108. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ignite Stemless Anatomic Shoulder System?

Ignite Stemless Anatomic Shoulder System is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Ignite Orthopedics, LLC. The 510(k) number is K203108.

When did Ignite Stemless Anatomic Shoulder System receive FDA 510(k) clearance?

Ignite Stemless Anatomic Shoulder System received FDA 510(k) clearance on 2021-07-16, under 510(k) number K203108.

Who is the listed applicant for Ignite Stemless Anatomic Shoulder System?

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

What is the FDA product code for Ignite Stemless Anatomic Shoulder System?

The FDA product code for Ignite Stemless Anatomic Shoulder System is PKC.

其他以 Ignite Orthopedics, 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。

K202716燃燒解剖肩關節系統

相關器械（代碼：PKC）

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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