M-Vizion Femoral Revision System

GUDID 07630971264359

Distal Stem Ø15mm L 220mm straight 4 degree

Medacta International SA

Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis
Primary Device ID07630971264359
NIH Device Record Key0bf57b21-edda-4954-abcc-5b442a34047b
Commercial Distribution StatusIn Commercial Distribution
Brand NameM-Vizion Femoral Revision System
Version Model Number01.22.564
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630971264359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-24

On-Brand Devices [M-Vizion Femoral Revision System]

07630030885143Locking Screw
07630030885136Proximal Body Ø20mm L 60mm LAT
07630030885112Proximal Body Ø20mm L 40mm LAT
07630030885105Proximal Body Ø20mm L 60mm STD
07630030885099Proximal Body Ø20mm L 50mm STD
07630030885082Proximal Body Ø20mm L 40mm STD
07630030885075Distal Stem Ø21mm
07630030885068Distal Stem Ø20mm
07630030885051Distal Stem Ø19mm
07630030885044Distal Stem Ø18mm
07630030885037Distal Stem Ø17mm
07630030885020Distal Stem Ø16mm
07630030885013Distal Stem Ø15mm
07630030885006Distal Stem Ø14mm
07630030884993Distal Stem Ø13mm
07630030884986Distal Stem Ø12mm L 140mm straight
07630030877148Proximal Body Ø20mm L 50mm LAT
07630971240896Distal Stem Ø26mm L 140mm straight
07630971240889Distal Stem Ø25mm L 140mm straight
07630971240872Distal Stem Ø24mm L 140mm straight
07630971240865Distal Stem Ø23mm L 140mm straight
07630971240858Distal Stem Ø22mm L 140mm straight
07630971240841Proximal Body Ø20mm L 90mm STD
07630971240834Proximal Body Ø20mm L 80mm STD
07630971238640Proximal Body Ø32mm L 90mm LAT
07630971238633Proximal Body Ø32mm L 80mm LAT
07630971238626Proximal Body Ø32mm L 70mm LAT
07630971238619Proximal Body Ø32mm L 60mm LAT
07630971238602Proximal Body Ø32mm L 50mm LAT
07630971238596Proximal Body Ø32mm L 40mm LAT
07630971238589Proximal Body Ø32mm L 90mm STD
07630971238572Proximal Body Ø32mm L 80mm STD
07630971238565Proximal Body Ø32mm L 70mm STD
07630971238558Proximal Body Ø32mm L 60mm STD
07630971238541Proximal Body Ø32mm L 50mm STD
07630971238534Proximal Body Ø32mm L 40mm STD
07630971238527Proximal Body Ø28mm L 90mm LAT
07630971238510Proximal Body Ø28mm L 80mm LAT
07630971238503Proximal Body Ø28mm L 70mm LAT
07630971238497Proximal Body Ø28mm L 60mm LAT
07630971238480Proximal Body Ø28mm L 50mm LAT
07630971238473Proximal Body Ø28mm L 40mm LAT
07630971238466Proximal Body Ø28mm L 90mm STD
07630971238459Proximal Body Ø28mm L 80mm STD
07630971238442Proximal Body Ø28mm L 70mm STD
07630971238435Proximal Body Ø28mm L 60mm STD
07630971238428Proximal Body Ø28mm L 50mm STD
07630971238411Proximal Body Ø28mm L 40mm STD
07630971238404Proximal Body Ø24mm L 90mm LAT
07630971238398Proximal Body Ø24mm L 80mm LAT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.