FDA 510(k)

Tritanium X PL可擴展後腰部金屬籠，Tritanium X TL可擴展曲型後腰部金屬籠

K 號：K183249 · 2019-07-25

決定日期2019-07-25

產品代碼MAX

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決定相當於

器材摘要

Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Spine. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K183249. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage?

Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Stryker Spine. The 510(k) number is K183249.

When did Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage receive FDA 510(k) clearance?

Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage received FDA 510(k) clearance on 2019-07-25, under 510(k) number K183249.

Who is the listed applicant for Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage?

FDA 510(k) 記錄將 Stryker Spine 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage?

The FDA product code for Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage is MAX.

其他以 Stryker Spine 為申請人之記錄

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相關器械（代碼：MAX）

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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