FDA 510(k)

OTS 髋關節

K 號：K232140 · 2024-03-11

決定日期2024-03-11

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

OTS Hip is the device name listed in this FDA 510(k) record. The listed applicant is Ortoma AB. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K232140. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OTS Hip?

OTS Hip is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Ortoma AB. The 510(k) number is K232140.

When did OTS Hip receive FDA 510(k) clearance?

OTS Hip received FDA 510(k) clearance on 2024-03-11, under 510(k) number K232140.

Who is the listed applicant for OTS Hip?

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

What is the FDA product code for OTS Hip?

The FDA product code for OTS Hip is OLO.

其他以 Ortoma AB 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。

K261852OTS 髋關節 K250086OTS 髋關節 K181449Ortoma治療解決方案 - OTS

相關器械（代碼：OLO）

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。

K262506Remex脊椎手術導航 - 適用儀器Remex Medical Corp.K261410Navbit MARQ (PRD-001-SUP（仰臥登錄套件），PRD-001-LAT（側臥登錄套件）)Suite 201, National Innovation Centre K261205脊椎藝術導航儀器系統Spineart SA K261024TMINI 微型機器人系統THINK Surgical, Inc.K262121離子-L導航儀器SurGenTec, LLC K261113Op.n™脊椎導航與機械導引Ecential Robotics

官方來源

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