FDA 510(k)

全面反向肩蓋 - HA 髖關節基板

K 號：K252404 · 2026-04-15

決定日期2026-04-15

產品代碼PHX

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決定相當於

器材摘要

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K252404. 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 Comprehensive Reverse Shoulder - HA Glenosphere Baseplates?

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Biomet Orthopedics. The 510(k) number is K252404.

When did Comprehensive Reverse Shoulder - HA Glenosphere Baseplates receive FDA 510(k) clearance?

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates received FDA 510(k) clearance on 2026-04-15, under 510(k) number K252404.

Who is the listed applicant for Comprehensive Reverse Shoulder - HA Glenosphere Baseplates?

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

What is the FDA product code for Comprehensive Reverse Shoulder - HA Glenosphere Baseplates?

The FDA product code for Comprehensive Reverse Shoulder - HA Glenosphere Baseplates is PHX.

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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。

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官方來源

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