Mectalif Transforaminal Cages

GUDID 07630030829192

Transforaminal Interbody Fusion Device 12x34x14 L5°

Medacta International SA

Metallic spinal interbody fusion cage

• Primary Device ID: 07630030829192
• NIH Device Record Key: 7e230a90-24b6-4a89-804a-bea35b42efe0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mectalif Transforaminal Cages
• Version Model Number: 03.23.078
• 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	07630030829192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131671

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2014-11-18

On-Brand Devices [Mectalif Transforaminal Cages]

• 07630030829277: Transforaminal Interbody Fusion Device 14x34x14 L5°
• 07630030829260: Transforaminal Interbody Fusion Device 14x34x12 L5°
• 07630030829253: Transforaminal Interbody Fusion Device 14x34x10 L5°
• 07630030829246: Transforaminal Interbody Fusion Device 14x34x15 L5°
• 07630030829239: Transforaminal Interbody Fusion Device 14x34x13 L5°
• 07630030829222: Transforaminal Interbody Fusion Device 14x34x11 L5°
• 07630030829215: Transforaminal Interbody Fusion Device 14x34x9 L5°
• 07630030829208: Transforaminal Interbody Fusion Device 14x34x8 L5°
• 07630030829192: Transforaminal Interbody Fusion Device 12x34x14 L5°
• 07630030829185: Transforaminal Interbody Fusion Device 12x34x12 L5°
• 07630030829178: Transforaminal Interbody Fusion Device 12x34x10 L5°
• 07630030829161: Transforaminal Interbody Fusion Device 12x34x15 L5°
• 07630030829154: Transforaminal Interbody Fusion Device 12x34x13 L5°
• 07630030829147: Transforaminal Interbody Fusion Device 12x34x11 L5°
• 07630030829130: Transforaminal Interbody Fusion Device 12x34x9 L5°
• 07630030829123: Transforaminal Interbody Fusion Device 12x34x8 L5°
• 07630030829116: Transforaminal Interbody Fusion Device 14x30x14 L5°
• 07630030829109: Transforaminal Interbody Fusion Device 14x30x12 L5°
• 07630030829093: Transforaminal Interbody Fusion Device 14x30x10 L5°
• 07630030829086: Transforaminal Interbody Fusion Device 14x30x15 L5°
• 07630030829079: Transforaminal Interbody Fusion Device 14x30x13 L5°
• 07630030829062: Transforaminal Interbody Fusion Device 14x30x11 L5°
• 07630030829055: Transforaminal Interbody Fusion Device 14x30x9 L5°
• 07630030829048: Transforaminal Interbody Fusion Device 14x30x8 L5°
• 07630030829031: Transforaminal Interbody Fusion Device 12x30x14 L5°
• 07630030829024: Transforaminal Interbody Fusion Device 12x30x12 L5°
• 07630030829017: Transforaminal Interbody Fusion Device 12x30x10 L5°
• 07630030829000: Transforaminal Interbody Fusion Device 12x30x15 L5°
• 07630030828997: Transforaminal Interbody Fusion Device 12x30x13 L5°
• 07630030828980: Transforaminal Interbody Fusion Device 12x30x11 L5°
• 07630030828973: Transforaminal Interbody Fusion Device 12x30x9 L5°
• 07630030828966: Transforaminal Interbody Fusion Device 12x30x8 L5°