FDA 510(k)

PERLA TL 後方骨板固定系統

K 號：K203222 · 2020-12-17

決定日期2020-12-17

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

PERLA TL Posterior Osteosynthesis System is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K203222. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PERLA TL Posterior Osteosynthesis System?

PERLA TL Posterior Osteosynthesis System is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Spineart. The 510(k) number is K203222.

When did PERLA TL Posterior Osteosynthesis System receive FDA 510(k) clearance?

PERLA TL Posterior Osteosynthesis System received FDA 510(k) clearance on 2020-12-17, under 510(k) number K203222.

Who is the listed applicant for PERLA TL Posterior Osteosynthesis System?

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

What is the FDA product code for PERLA TL Posterior Osteosynthesis System?

The FDA product code for PERLA TL Posterior Osteosynthesis System is NKB.

其他以 Spineart 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。

K230774PERLA® TL 系統；TEKTONA® HV US 骨水泥 K213470PERLA® TL 後方骨板固定系統 K210472脊椎藝術導航儀器系統 K203506PERLA® TL後方骨板固定系統 K200571PERLA® 頸胸椎後固定系統 K200312Tryptik Ti

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相關器械（代碼：NKB）

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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