Mpact Extension

GUDID 07630971257542

Cancellous bone screw Ø 6.5 L 60

Medacta International SA

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 07630971257542
• NIH Device Record Key: f2038f4c-6b85-4500-b459-75a5f547fd5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpact Extension
• Version Model Number: 01.43.0060
• 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: false
• 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	07630971257542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200391

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2021-05-10
• Device Publish Date: 2021-04-30

On-Brand Devices [Mpact Extension]

• 07630971257566: Cancellous bone screw Ø 6.5 L 70
• 07630971257559: Cancellous bone screw Ø 6.5 L 65
• 07630971257542: Cancellous bone screw Ø 6.5 L 60
• 07630971257535: Cancellous bone screw Ø 6.5 L 55
• 07630971257528: Cancellous bone screw Ø 6.5 L 50
• 07630971257511: Cancellous bone screw Ø 6.5 L 45
• 07630971257504: Cancellous bone screw Ø 6.5 L 40
• 07630971257498: Cancellous bone screw Ø 6.5 L 35
• 07630971257481: Cancellous bone screw Ø 6.5 L 30
• 07630971257474: Cancellous bone screw Ø 6.5 L 25
• 07630971257467: Cancellous bone screw Ø 6.5 L 20
• 07630971257450: Cancellous bone screw Ø 6.5 L 15