LZO

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

产品代码
LZO
器械名称
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 888.3353
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)
34 件
其中 Summary 已存档
28 份,可直接下载
FDA 历史累计 510(k)
532 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)(34 件)

数据窗口为最近三年。最新一件:2026-07-06。

510(k) 号批准日期申请人器械名称摘要
K2610092026-07-06Waldemar Link GmbH & Co. KGMobileLink Acetabular Cup System – 40mm ID Inserts (PDF
K2608312026-06-16Zimmer, Inc.Z1 Hip SystemPDF
K2601822026-04-27Zimmer, Inc.Avenir® Müller Stem; Avenir Complete™ Hip SystemPDF
K2600372026-03-30Implantcast GmbHimplantcast Packaging System UpdatePDF
K2524012026-03-12Implantcast GmbHimplaFit® short stemsPDF
K2531712026-01-15Maxx Orthopedics, Inc.Libertas Taper Short (TS) Uncemented Femoral Stem (LPDF
K2504502025-09-19Medacta International S.A.Coated hip implantsPDF
K2430212025-08-07Signature Orthopaedics Pty, Ltd.Longboard Revision Hip StemPDF
K2519062025-07-18Zimmer, Inc.Z1 Hip SystemPDF
K2512922025-05-23Depuy Ireland UCRECLAIM Monobloc Revision Femoral StemPDF
K2439272025-05-16Waldemar Link GmbH & Co. KGMobileLink Acetabular Cup System - inhouse coatingsPDF
K2504442025-05-15Microport Orthopedics, Inc.NEXUS® Hip StemPDF
K2430432025-05-02Signature Orthopaedics Pty, Ltd.Origin™ Cemented Hip StemPDF
K2508342025-04-18Zimmer BiometZimmer Biomet Ceramic Heads (22.2mm diameter)PDF
K2505712025-03-28Smith & Nephew, Inc.CATALYSTEM Femoral StemsPDF
K2430292025-03-11Signature Orthopaedics Pty, Ltd.Origin™ TT StemPDF
K2417672025-03-06Medacta International S.A.Versacem Acetabular Shell and Double Mobility HC LinPDF
K2438092025-03-04LimacorporateBiolox® Delta Revision headsFDA
K2414832025-02-07Encore Medical L.P.ceramys™ femoral head systemPDF
K2434662025-01-06United Orthopedic CorporationConformity Stem Extension Line, #0PDF
K2434442024-12-05Kyocera CorporationBIOCERAM AZUL® HEADPDF
K2405282024-11-15B-One Ortho, Corp.b-ONE® Total Hip SystemPDF
K2403912024-10-24Implantcast GmbHMUTARS® femoral stem cemented 160 mm and 200 mmFDA
K2422492024-08-30United Orthopedic CorporationConformity Stem Extension LineFDA
K2412412024-08-27Orchard Medical Development, LLCZ1 Cemented Hip SystemPDF
K2403812024-06-27Smith & Nephew, Inc.CATALYSTEM Femoral StemsFDA
K2408342024-06-03Implantcast GmbHEcoFit® short stem cementless cpTiPDF
K2340252024-04-24Howmedica Osteonics Corp., Dba Stryker22.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsPDF
K2404522024-04-12Microport Orthopedics, Inc.Ceramic Femoral HeadPDF
K2337242024-03-11Howmedica Osteonics Corp., Dba Stryker28mm/38D MDM X3 Insert for MDM LinerFDA
K2334762024-02-08Orchard Medical DevelopmentZ1 Hip SystemFDA
K2237452023-12-22SerfNovae® Dual Mobility System, Hype® Hip SystemPDF
K2323712023-10-19Implantcast GmbHActinia® hip stemsPDF
K2332332023-10-11Depuy Ireland UCEMPHASYS Femoral StemsPDF

其中 28 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: LZO
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。