FDA 510(k)

ORTHOLOC™ SPS 肩部固定系統

K 號：K191711 · 2019-07-17

決定日期2019-07-17

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

ORTHOLOC™ SPS Shoulder Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) number K191711. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ORTHOLOC™ SPS Shoulder Plating System?

ORTHOLOC™ SPS Shoulder Plating System is a medical device that received FDA 510(k) clearance on 2019-07-17. The listed applicant is Tornier, Inc.. The 510(k) number is K191711.

When did ORTHOLOC™ SPS Shoulder Plating System receive FDA 510(k) clearance?

ORTHOLOC™ SPS Shoulder Plating System received FDA 510(k) clearance on 2019-07-17, under 510(k) number K191711.

Who is the listed applicant for ORTHOLOC™ SPS Shoulder Plating System?

FDA 510(k) 記錄將 Tornier, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ORTHOLOC™ SPS Shoulder Plating System?

The FDA product code for ORTHOLOC™ SPS Shoulder Plating System is HRS.

其他以 Tornier, Inc. 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。

K260721Tornier Perform 高級肩胛盂 K252788Tornier Perform™ 反向單柱盂蓋 (Perform Mono)K251686Tornier 臂骨重建系統 Max (Tornier HRS Max)K230352Tornier肩胛骨釘與Tornier長肩胛骨釘 K220914Tornier Perform 臂骨系統 – 骨折 K220418Tornier Perform 臂骨系統 – 齒冠式

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相關器械（代碼：HRS）

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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