FDA 510(k)

SyndesMetrics 骨折修復系統

K 號：K172620 · 2017-11-08

決定日期2017-11-08

產品代碼HTN

諮詢委員會或

決定相當於

器材摘要

SyndesMetrics Syndesmosis Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Mortise Medical, LLC. It received FDA 510(k) clearance on 2017-11-08 under 510(k) number K172620. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SyndesMetrics Syndesmosis Repair System?

SyndesMetrics Syndesmosis Repair System is a medical device that received FDA 510(k) clearance on 2017-11-08. The listed applicant is Mortise Medical, LLC. The 510(k) number is K172620.

When did SyndesMetrics Syndesmosis Repair System receive FDA 510(k) clearance?

SyndesMetrics Syndesmosis Repair System received FDA 510(k) clearance on 2017-11-08, under 510(k) number K172620.

Who is the listed applicant for SyndesMetrics Syndesmosis Repair System?

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

What is the FDA product code for SyndesMetrics Syndesmosis Repair System?

The FDA product code for SyndesMetrics Syndesmosis Repair System is HTN.

其他以 Mortise Medical, LLC 為申請人之記錄

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相關器械（代碼：HTN）

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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