FDA 510(k)

Catalyst R1 頸部外翻系統

K 號：K213349 · 2022-06-23

決定日期2022-06-23

產品代碼PHX

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決定相當於

器材摘要

Catalyst R1 Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K213349. 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 Catalyst R1 Reverse Shoulder System?

Catalyst R1 Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K213349.

When did Catalyst R1 Reverse Shoulder System receive FDA 510(k) clearance?

Catalyst R1 Reverse Shoulder System received FDA 510(k) clearance on 2022-06-23, under 510(k) number K213349.

Who is the listed applicant for Catalyst R1 Reverse Shoulder System?

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

What is the FDA product code for Catalyst R1 Reverse Shoulder System?

The FDA product code for Catalyst R1 Reverse Shoulder System is PHX.

其他以 Catalyst Orthoscience, Inc. 為申請人之記錄

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K252418催化劑F1x肩部系統 K234105催化劑F1x肩部系統 K232583Catalyst R1 頸部外翻系統 K223655Catalyst R1 頸部外翻系統 K222317催化 EA 可轉接式肩部針 K211991Catalyst R1 頸部外翻系統

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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肩部系統Restor3D K261683Augment 偏心儀器系統Zimmer, Inc.K260102Tornier Perform Reversed Glenoid和Tornier Perform Reversed Augmented Glenoid Shoulder System的設備名稱Stryker Corporation (Tornier, Inc.)K261016MSS - 肱骨反覆蓋擴充件Medacta International, SA K253992Veritas逆向全肩關節系統Restor3D K252404全面反向肩蓋 - HA 髖關節基板Biomet Orthopedics

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