Navigation System for Knee surgery

GUDID 07630030846656

Passive Markers (18 pieces)

Medacta International SA

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 07630030846656
• NIH Device Record Key: 615264f2-5d30-4948-bcbb-e79e3b5392c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation System for Knee surgery
• Version Model Number: 33.22.0052
• 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	07630030846656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083872

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2026-01-27
• Device Publish Date: 2026-01-19

On-Brand Devices [Navigation System for Knee surgery]

• 07630030846663: Passive Markers (3 pieces)
• 07630030846656: Passive Markers (18 pieces)
• 07630699701792: iMNS Navigator x US
• 07630345728975: iMNS Navigator