FDA 510(k)

藍圖™ 病患專屬儀器設備

K 號：K203315 · 2021-04-15

決定日期2021-04-15

產品代碼KWS

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 Tornier S.A.S.. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K203315. The device is classified under product code KWS. 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 2021-04-15. The listed applicant is Tornier S.A.S.. The 510(k) number is K203315.

When did BLUEPRINT™ Patient Specific Instrumentation receive FDA 510(k) clearance?

BLUEPRINT™ Patient Specific Instrumentation received FDA 510(k) clearance on 2021-04-15, under 510(k) number K203315.

Who is the listed applicant for BLUEPRINT™ Patient Specific Instrumentation?

The FDA 510(k) record lists 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 KWS.

其他以 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。

K232265藍圖™ 病患專屬儀器設備 K222510藍圖雜交實境系統 K190521Aequalis 升降柔軟肩關節系統 K162800藍圖病人特定儀器 K161789藍圖病人特定儀器 K153452Salto XT, Salto Talaris

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相關器械（代碼：KWS）

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Tornier, Inc.K254084AETOS肩關節系統 - CONCELOC關節盤Smith & Nephew, Inc.K252418催化劑F1x肩部系統Catalyst Orthoscience, Inc.K252416AETOS肩關節系統 Meta 肱骨假體尺寸 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier肩胛骨重建系統（Tornier HRS）；Tornier Perform肩胛骨系統 - 植骨（Tornier PHS-Stem）Stryker Corporation (Tornier, Inc.)

官方來源

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