FDA 510(k)

Physica KR Liner 及 SMR Reverse 臂軸 Liner

K 號：K190911 · 2019-11-26

決定日期2019-11-26

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Physica KR Liner and SMR Reverse Humeral Liner is the device name listed in this FDA 510(k) record. The listed applicant is Limacorporate. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K190911. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Physica KR Liner and SMR Reverse Humeral Liner?

Physica KR Liner and SMR Reverse Humeral Liner is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Limacorporate. The 510(k) number is K190911.

When did Physica KR Liner and SMR Reverse Humeral Liner receive FDA 510(k) clearance?

Physica KR Liner and SMR Reverse Humeral Liner received FDA 510(k) clearance on 2019-11-26, under 510(k) number K190911.

Who is the listed applicant for Physica KR Liner and SMR Reverse Humeral Liner?

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

What is the FDA product code for Physica KR Liner and SMR Reverse Humeral Liner?

The FDA product code for Physica KR Liner and SMR Reverse Humeral Liner is JWH.

其他以 Limacorporate 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。

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相關器械（代碼：JWH）

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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