FDA 510(k)

藍圖病人特定儀器

K 號：K253674 · 2026-04-03

申請人Stryker Corporation (Tornier, S.A.S.)

決定日期2026-04-03

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

Blueprint Patient-Specific Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, S.A.S.). It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K253674. 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 Blueprint Patient-Specific Instrumentation?

Blueprint Patient-Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Stryker Corporation (Tornier, S.A.S.). The 510(k) number is K253674.

When did Blueprint Patient-Specific Instrumentation receive FDA 510(k) clearance?

Blueprint Patient-Specific Instrumentation received FDA 510(k) clearance on 2026-04-03, under 510(k) number K253674.

Who is the listed applicant for Blueprint Patient-Specific Instrumentation?

The FDA 510(k) record lists Stryker Corporation (Tornier, S.A.S.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blueprint Patient-Specific Instrumentation?

The FDA product code for Blueprint Patient-Specific Instrumentation is PHX.

其他以 Stryker Corporation (Tornier, S.A.S.) 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。

K241491藍圖病人特定儀器；肩部 iD 主要反向關節盂

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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