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MAI

Fastener, Fixation, Biodegradable, Soft Tissue

产品代码
MAI
器械名称
Fastener, Fixation, Biodegradable, Soft Tissue
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 888.3030
FDA 专业组
Orthopedic
上市路径
需提交 510(k) 上市前通告
标记
属植入器械
该代码近三年的 510(k)
21 件
其中 Summary 已存档
21 份,可直接下载
FDA 历史累计 510(k)
221 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(21 件)

数据窗口为最近三年。最新一件:2026-08-07。

510(k) 号批准日期申请人器械名称摘要
K2623572026-08-07Arthrex, Inc.Arthrex Bioabsorbable PushLock Suture AnchorsPDF
K2539312026-05-28Arthrex, Inc.Arthrex Bioabsorbable PushLock Suture AnchorsPDF
K2602942026-03-27Surgical Fusion Technologies GmbHSF Push-in AnchorPDF
K2540552026-02-24OSSIO , Ltd.OSSIOfiber® Suture AnchorPDF
K2516802026-02-17Biocomposites, Ltd.Biosteon® ScrewPDF
K2529462025-10-15Conmed CorporationBioBrace® Extra-Articular Ligament Augmentation KitPDF
K2520222025-08-19OSSIO , Ltd.OSSIOfiber® Interference ScrewPDF
K2513092025-05-27OSSIO , Ltd.OSSIOfiber® Suture AnchorPDF
K2505442025-05-23Stryker EndoscopyKnotilus+ Biocomposite Knotless AnchorPDF
K2505282025-05-21Stryker EndoscopyStryker AlphaVent™ Knotless SP Biocomposite AnchorPDF
K2437602025-04-03OSSIO , Ltd.OSSIOfiber® Suture Anchor 2.5-3.5 mmPDF
K2505262025-03-14Arthrex, Inc.Arthrex 4.75 mm Double Loaded Knotless Corkscrew Sut…PDF
K2437902025-02-05Depuy MitekGRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorPDF
K2434672024-12-03Osteonic Co., Ltd.Fix2Lock (Biocomposite medial, Biocomposite lateral,…PDF
K2410102024-09-11Depuy MitekHEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self…PDF
K2419122024-07-29Nanofiber Solutions, LLCBIOCHARGEPDF
K2339712024-06-04Arthrex, Inc.Arthrex AlloSync PushLock Suture AnchorPDF
K2402882024-04-01Surgical Fusion Technologies GmbHSF Push- in AnchorPDF
K2404412024-03-15Depuy MitekMILAGRO Interference Screw; MILAGRO ADVANCE Interfer…PDF
K2400902024-03-05Conmed CorporationArgo Knotless GENESYS AnchorPDF
K2325132023-09-18Parcus MedicalX-Twist Biocomposite Suture AnchorPDF

其中 21 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: MAI
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。