FDA 510(k)

SPIRA-T 斜後腰椎間隔器，SPIRA-P 後腰椎間隔器

K 號：K210595 · 2021-06-15

決定日期2021-06-15

產品代碼MAX

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決定相當於

器材摘要

SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2021-06-15 under 510(k) number K210595. 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 SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers?

SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers is a medical device that received FDA 510(k) clearance on 2021-06-15. The listed applicant is Camber Spine Technologies, LLC. The 510(k) number is K210595.

When did SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers receive FDA 510(k) clearance?

SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers received FDA 510(k) clearance on 2021-06-15, under 510(k) number K210595.

Who is the listed applicant for SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers?

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

What is the FDA product code for SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers?

The FDA product code for SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers is MAX.

其他以 Camber Spine Technologies, LLC 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。

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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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