FDA 510(k)

可擴展式钛合金PLIF/TLIF系統

K 號：K253377 · 2025-10-24

決定日期2025-10-24

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Expandable Titanium PLIF/TLIF System is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Spine, Inc.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K253377. 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 Expandable Titanium PLIF/TLIF System?

Expandable Titanium PLIF/TLIF System is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Spectrum Spine, Inc.. The 510(k) number is K253377.

When did Expandable Titanium PLIF/TLIF System receive FDA 510(k) clearance?

Expandable Titanium PLIF/TLIF System received FDA 510(k) clearance on 2025-10-24, under 510(k) number K253377.

Who is the listed applicant for Expandable Titanium PLIF/TLIF System?

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

What is the FDA product code for Expandable Titanium PLIF/TLIF System?

The FDA product code for Expandable Titanium PLIF/TLIF System is MAX.

其他以 Spectrum Spine, Inc. 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。

K243074Spectrum脊椎腰椎籠架系統 K240838Spectrum脊椎頸椎籠架系統

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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官方來源

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