FDA 510(k)

精準骨斷術™

K 號：K240703 · 2024-04-12

決定日期2024-04-12

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Fine Osteotomy™ is the device name listed in this FDA 510(k) record. The listed applicant is Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K240703. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fine Osteotomy™?

Fine Osteotomy™ is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Bodycad Laboratories, Inc.. The 510(k) number is K240703.

When did Fine Osteotomy™ receive FDA 510(k) clearance?

Fine Osteotomy™ received FDA 510(k) clearance on 2024-04-12, under 510(k) number K240703.

Who is the listed applicant for Fine Osteotomy™?

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

What is the FDA product code for Fine Osteotomy™?

The FDA product code for Fine Osteotomy™ is HRS.

其他以 Bodycad Laboratories, Inc. 為申請人之記錄

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K253300精準骨斷術™K250394精細TTO™K250923精準骨斷術™K241356精準骨斷術™K240066精準骨斷術™K231314精準骨斷術™

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相關器械（代碼：HRS）

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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