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FDA 510(k)

Integra TITAN Reverse Shoulder System

K 號：K161189 · 2016-08-25

申請人Integra LifeSciences Corporation
決定日期2016-08-25
產品代碼PHX
諮詢委員會OR
決定Substantially Equivalent

器材摘要

Integra TITAN Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161189. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Integra TITAN Reverse Shoulder System?

Integra TITAN Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K161189.

When did Integra TITAN Reverse Shoulder System receive FDA 510(k) clearance?

Integra TITAN Reverse Shoulder System received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161189.

Who is the listed applicant for Integra TITAN Reverse Shoulder System?

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

What is the FDA product code for Integra TITAN Reverse Shoulder System?

The FDA product code for Integra TITAN Reverse Shoulder System is PHX.

相關臨床試驗

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其他以 Integra LifeSciences Corporation 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：PHX）

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。

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

官方來源

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