MectaLIF Anterior System

GUDID 07630030833748

Anterior Interbody Fusion Device 24x31x10 L5°

Medacta International SA

Metallic spinal interbody fusion cage

• Primary Device ID: 07630030833748
• NIH Device Record Key: 97cd2910-eba9-46a3-b46f-48671d7394b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaLIF Anterior System
• Version Model Number: 03.31.001
• 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	07630030833748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160605

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-07-26

On-Brand Devices [MectaLIF Anterior System]

• 07630030875519: Plate Hybrid H.18 mm
• 07630030875502: Plate Hybrid H.16 mm
• 07630030875496: Plate Hybrid H.14 mm
• 07630030875489: Enhanced Screw Diam.5.5x40 (Double Packaging)
• 07630030875472: Enhanced Screw Diam.5.5x35 (Double Packaging)
• 07630030875465: Enhanced Screw Diam.5.5x30 (Double Packaging)
• 07630030875458: Enhanced Screw Diam.5.5x25 (Double Packaging)
• 07630030875441: Enhanced Screw Diam.5x40 (Double Packaging)
• 07630030875434: Enhanced Screw Diam.5x35 (Double Packaging)
• 07630030875427: Enhanced Screw Diam.5x30 (Double Packaging)
• 07630030875410: Enhanced Screw Diam.5x25 (Double Packaging)
• 07630030875403: Enhanced Screw Diam.5.5x40
• 07630030875397: Enhanced Screw Diam.5.5x35
• 07630030875380: Enhanced Screw Diam.5.5x30
• 07630030875373: Enhanced Screw Diam.5.5x25
• 07630030875366: Enhanced Screw Diam.5x40
• 07630030875359: Enhanced Screw Diam.5x35
• 07630030875342: Enhanced Screw Diam.5x30
• 07630030861109: Plate Hybrid H.12 mm
• 07630030861093: Enhanced Screw Diam.5x25
• 07630030861086: Screw Diam.5.5x40 (Double packaging)
• 07630030861079: Screw Diam.5x40 (Double packaging)
• 07630030861062: Screw Diam.5.5x40
• 07630030861055: Screw Diam.5x40
• 07630030834035: Anterior Interbody Fusion Device 27x35x18 L15°
• 07630030834028: Anterior Interbody Fusion Device 27x35x16 L15°
• 07630030834011: Anterior Interbody Fusion Device 27x35x14 L15°
• 07630030834004: Anterior Interbody Fusion Device 27x35x12 L15°
• 07630030833991: Anterior Interbody Fusion Device 27x35x10 L15°
• 07630030833984: Anterior Interbody Fusion Device 27x35x18 L10°
• 07630030833977: Anterior Interbody Fusion Device 27x35x16 L10°
• 07630030833960: Anterior Interbody Fusion Device 27x35x14 L10°
• 07630030833953: Anterior Interbody Fusion Device 27x35x12 L10°
• 07630030833946: Anterior Interbody Fusion Device 27x35x10 L10°
• 07630030833939: Anterior Interbody Fusion Device 27x35x18 L5°
• 07630030833922: Anterior Interbody Fusion Device 27x35x16 L5°
• 07630030833915: Anterior Interbody Fusion Device 27x35x14 L5°
• 07630030833908: Anterior Interbody Fusion Device 27x35x12 L5°
• 07630030833892: Anterior Interbody Fusion Device 27x35x10 L5°
• 07630030833885: Anterior Interbody Fusion Device 24x31x18 L15°
• 07630030833878: Anterior Interbody Fusion Device 24x31x16 L15°
• 07630030833861: Anterior Interbody Fusion Device 24x31x14 L15°
• 07630030833854: Anterior Interbody Fusion Device 24x31x12 L15°
• 07630030833847: Anterior Interbody Fusion Device 24x31x10 L15°
• 07630030833830: Anterior Interbody Fusion Device 24x31x18 L10°
• 07630030833823: Anterior Interbody Fusion Device 24x31x16 L10°
• 07630030833816: Anterior Interbody Fusion Device 24x31x14 L10°
• 07630030833809: Anterior Interbody Fusion Device 24x31x12 L10°
• 07630030833793: Anterior Interbody Fusion Device 24x31x10 L10°
• 07630030833786: Anterior Interbody Fusion Device 24x31x18 L5°