TETRIS II 8° T2K8071124

GUDID 04047844010679

The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is avaiable in a variety of sizes and angulations thereby enabling the surgeon to choose the size best united to the individual pathology and anatomical condition.

SIGNUS Medizintechnik GmbH

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• Primary Device ID: 04047844010679
• NIH Device Record Key: 2d2d2f7c-2a38-409d-916b-0b7e4a6312b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TETRIS II 8°
• Version Model Number: Lumbar cage, angled
• Catalog Number: T2K8071124
• Company DUNS: 344203948
• Company Name: SIGNUS Medizintechnik GmbH
• 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: true
• 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

Customer Support Contacts

• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844010679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122317
• Premarket Notification: K123758

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: 6
• Public Version Date: 2019-10-24
• Device Publish Date: 2015-09-24

On-Brand Devices [TETRIS II 8°]

• 04047844011140: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844011119: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844011096: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844011072: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844011058: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844011027: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010990: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010969: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010938: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010884: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010853: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010822: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010792: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010761: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010730: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010709: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010679: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
• 04047844010648: The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l