FDA 510(k)

LigaPASS™ 2.0 韧帶增強系統

K 號：K213659 · 2022-05-24

決定日期2022-05-24

產品代碼OWI

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決定相當於

器材摘要

LigaPASS™ 2.0 Ligament Augmentation System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2022-05-24 under 510(k) number K213659. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LigaPASS™ 2.0 Ligament Augmentation System?

LigaPASS™ 2.0 Ligament Augmentation System is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Medicrea International SA. The 510(k) number is K213659.

When did LigaPASS™ 2.0 Ligament Augmentation System receive FDA 510(k) clearance?

LigaPASS™ 2.0 Ligament Augmentation System received FDA 510(k) clearance on 2022-05-24, under 510(k) number K213659.

Who is the listed applicant for LigaPASS™ 2.0 Ligament Augmentation System?

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

What is the FDA product code for LigaPASS™ 2.0 Ligament Augmentation System?

The FDA product code for LigaPASS™ 2.0 Ligament Augmentation System is OWI.

其他以 Medicrea International SA 為申請人之記錄

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相關器械（代碼：OWI）

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。

K261374LigaPASS™ 系統Medicrea International S.A.S K253615無敵帶系統Alphatec Spine, Inc.K222097奧林匹克畸形帶系統Astura Medical K230565HILINE™ 固定系統Globus Medical, Inc.K211057LigaPASS®脊椎系統，CD Horizon™脊椎系統Medtronic, Inc.K201240航海帽系統SeaSpine Orthopedics Corporation

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