M-Vizion Femoral Revision System

GUDID 07630345707437

Monoblock stem ø12mm L 190mm STD

Medacta International SA

Revision coated hip femur prosthesis

• Primary Device ID: 07630345707437
• NIH Device Record Key: a118c65b-ca4c-483f-bf75-bd5a8e6930df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-Vizion Femoral Revision System
• Version Model Number: 01.22.601
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630345707437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212327

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-01
• Device Publish Date: 2022-08-24

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

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