FDA 510(k)

SYNMESH 系統

K 號：K183054 · 2019-05-23

決定日期2019-05-23

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

SYNMESH System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Synthes Spine. It received FDA 510(k) clearance on 2019-05-23 under 510(k) number K183054. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SYNMESH System?

SYNMESH System is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Depuy Synthes Spine. The 510(k) number is K183054.

When did SYNMESH System receive FDA 510(k) clearance?

SYNMESH System received FDA 510(k) clearance on 2019-05-23, under 510(k) number K183054.

Who is the listed applicant for SYNMESH System?

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

What is the FDA product code for SYNMESH System?

The FDA product code for SYNMESH System is MQP.

其他以 Depuy Synthes Spine 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。

K181231德普伊森斯 T-PAL 間隔系統

相關器械（代碼：MQP）

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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