FDA 510(k)

My3D® 个性化骨盆重建設備

K 號：K223348 · 2023-01-30

決定日期2023-01-30

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

My3D® Personalized Pelvic Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2023-01-30 under 510(k) number K223348. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the My3D® Personalized Pelvic Reconstruction?

My3D® Personalized Pelvic Reconstruction is a medical device that received FDA 510(k) clearance on 2023-01-30. The listed applicant is Onkos Surgical, Inc.. The 510(k) number is K223348.

When did My3D® Personalized Pelvic Reconstruction receive FDA 510(k) clearance?

My3D® Personalized Pelvic Reconstruction received FDA 510(k) clearance on 2023-01-30, under 510(k) number K223348.

Who is the listed applicant for My3D® Personalized Pelvic Reconstruction?

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

What is the FDA product code for My3D® Personalized Pelvic Reconstruction?

The FDA product code for My3D® Personalized Pelvic Reconstruction is LPH.

其他以 Onkos Surgical, Inc. 為申請人之記錄

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相關器械（代碼：LPH）

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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