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FDA 510(k)

4CIS PEEK PLIF 金屬網籠，4CIS Pebble Beach PEEK PLIF 金屬網籠，4CIS Torrey Pines PEEK TLIF 金屬網籠，4CIS Dunes PEEK DLIF 金屬網籠，4CIS Augusta PEEK ALIF 金屬網籠

K 號：K190563 · 2019-09-18

申請人Solco Biomedical Co., Ltd.
決定日期2019-09-18
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K190563. 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 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage?

4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K190563.

When did 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage receive FDA 510(k) clearance?

4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage received FDA 510(k) clearance on 2019-09-18, under 510(k) number K190563.

Who is the listed applicant for 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage?

The FDA 510(k) record lists Solco Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage?

The FDA product code for 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage is MAX.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Solco Biomedical Co., Ltd. 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。

K2316554CIS®奇龍脊椎固定系統K2032334CIS 查里翁脊柱固定系統K1920444CIS 馬林 PEEK ACIF 金屬網籠K1904714CIS®奇龍脊椎固定系統K1824894CIS®派恩赫斯特前頸椎板系統K1624024CIS®馬林ACIF籠架系統

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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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官方來源

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