FDA 510(k)

CEPTRE® 結節型超高分子量聚乙烯縫線 PEEK 鈎釘

K 號：K231033 · 2024-01-04

決定日期2024-01-04

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

CEPTRE® Knotted UHMWPE Suture PEEK Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Healthium Medtech Limited. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K231033. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

CEPTRE® Knotted UHMWPE Suture PEEK Anchor is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Healthium Medtech Limited. The 510(k) number is K231033.

When did CEPTRE® Knotted UHMWPE Suture PEEK Anchor receive FDA 510(k) clearance?

CEPTRE® Knotted UHMWPE Suture PEEK Anchor received FDA 510(k) clearance on 2024-01-04, under 510(k) number K231033.

Who is the listed applicant for CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

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

What is the FDA product code for CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

The FDA product code for CEPTRE® Knotted UHMWPE Suture PEEK Anchor is MBI.

其他以 Healthium Medtech Limited 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。

K230891SURESTITCH™ UHMWPE 緝合釘 PEEK 植片半月板修復植入體 K232886INFILOOP® 固定環 UHMWPE 緝合釘鈦金屬按鈕 K231404T-Button® 調節式環形 UHMWPE 緝線 PEEK 按鈕，關閉按鈕，T-Button® S 調節式環形 UHMWPE 緝線 PEEK 按鈕，開啟按鈕 K223889Stativ® 結節超高分子量聚乙烯縫合釘

相關器械（代碼：MBI）

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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

官方來源

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