FDA 510(k)

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length

K 號：K213580 · 2021-12-03

決定日期2021-12-03

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K213580. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K213580.

When did Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length receive FDA 510(k) clearance?

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length received FDA 510(k) clearance on 2021-12-03, under 510(k) number K213580.

Who is the listed applicant for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

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

What is the FDA product code for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

The FDA product code for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is LZO.

其他以 Total Joint Othopedics, Inc. 為申請人之記錄

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相關器械（代碼：LZO）

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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