FDA 510(k)

Spectrum脊椎頸椎籠架系統

K 號：K240838 · 2024-05-30

決定日期2024-05-30

產品代碼ODP

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決定相當於

器材摘要

Spectrum Spine Cervical Cage 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 2024-05-30 under 510(k) number K240838. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spectrum Spine Cervical Cage System?

Spectrum Spine Cervical Cage System is a medical device that received FDA 510(k) clearance on 2024-05-30. The listed applicant is Spectrum Spine, Inc.. The 510(k) number is K240838.

When did Spectrum Spine Cervical Cage System receive FDA 510(k) clearance?

Spectrum Spine Cervical Cage System received FDA 510(k) clearance on 2024-05-30, under 510(k) number K240838.

Who is the listed applicant for Spectrum Spine Cervical Cage 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 Spectrum Spine Cervical Cage System?

The FDA product code for Spectrum Spine Cervical Cage System is ODP.

其他以 Spectrum Spine, Inc. 為申請人之記錄

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K253377可擴展式钛合金PLIF/TLIF系統 K243074Spectrum脊椎腰椎籠架系統

相關器械（代碼：ODP）

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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