MectaLIF Anterior Simple

GUDID 07630030875533

MectaLIF Anterior Simple H.14 mm

Medacta International SA

Metallic spinal interbody fusion cage

• Primary Device ID: 07630030875533
• NIH Device Record Key: 9826cd5a-76b7-49de-a1ea-91cf4d91b035
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaLIF Anterior Simple
• Version Model Number: 03.30.253
• 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	07630030875533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200048

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2020-03-25
• Device Publish Date: 2020-03-17

On-Brand Devices [MectaLIF Anterior Simple]

• 07630030875557: MectaLIF Anterior Simple H.18 mm
• 07630030875540: MectaLIF Anterior Simple H.16 mm
• 07630030875533: MectaLIF Anterior Simple H.14 mm
• 07630030875526: MectaLIF Anterior Simple H.12 mm
• 07630030861116: MectaLIF Anterior Simple H.10 mm