FDA.report

510(k) K230011

Device
Mpact Extension
Applicant
Medacta International S.A.
510(k) number
K230011
Product code
LPH
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-20
Date received
2023-01-03
Regulation
888.3358
Classification name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Stefano Baj
Address
Strada Regina Castel San Pietro (Ch) CH CH-6874 CH-6874

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
07630345798725Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798817Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798800Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798794Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798787Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798770Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798763Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798756Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798749Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798732Mpact Acetabular SystemMedacta International SA2023-09-28
07630542722202Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798718Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798701Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798695Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798688Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798671Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798664Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798657Mpact Acetabular SystemMedacta International SA2023-09-28
07630345798633Mpact Acetabular SystemMedacta International SA2023-09-28
07630971251816Mpact Acetabular SystemMedacta International SA2023-09-28
07630971257405Mpact Acetabular SystemMedacta International SA2023-09-28
07630971257382Mpact Acetabular SystemMedacta International SA2023-09-28
07630971257368Mpact Acetabular SystemMedacta International SA2023-09-28
07630971257344Mpact Acetabular SystemMedacta International SA2023-09-28
07630971256330Mpact Acetabular SystemMedacta International SA2023-09-28
07630971256323Mpact Acetabular SystemMedacta International SA2023-09-28
07630971256316Mpact Acetabular SystemMedacta International SA2023-09-28
07630971256309Mpact Acetabular SystemMedacta International SA2023-09-28
07630971251823Mpact Acetabular SystemMedacta International SA2023-09-28
07630971259195Mpact Acetabular SystemMedacta International SA2023-09-28

Other 510(k) Records For Product Code LPH

510(k)DeviceApplicantDecision date
K252623G7® Revision Acetabular SystemZimmer, Inc.2026-02-04
K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.2026-01-28
K252067Velora Acetabular SystemRestor3D, Inc.2025-12-05
K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.2025-11-12
K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.2025-08-29
K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.2025-06-06
K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited2025-06-05
K242232Mpact 3D Metal Augments IIMedacta International S.A.2025-04-23
K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.2025-04-10
K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-02-06
K243977EMPHASYS Acetabular SystemDepuy Ireland UC2025-01-22
K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A2025-01-13
K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG2024-11-08