FDA 510(k)

PERLA® TL後方骨板固定系統

K 號：K203506 · 2021-01-15

決定日期2021-01-15

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 2021-01-15 under 510(k) number K203506. 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 2021-01-15. The listed applicant is Spineart. The 510(k) number is K203506.

When did PERLA® TL posterior osteosynthesis system receive FDA 510(k) clearance?

PERLA® TL posterior osteosynthesis system received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203506.

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 K203222PERLA 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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