NOVAL 0° NV001848

GUDID 04047844009376

The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

SIGNUS Medizintechnik GmbH

Polymeric spinal fusion cage, sterile

• Primary Device ID: 04047844009376
• NIH Device Record Key: 1107530a-acbb-4424-9638-e7b9ea587440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVAL 0°
• Version Model Number: Lumbar cage, straight
• Catalog Number: NV001848
• 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	04047844009376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111792

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: 5
• Public Version Date: 2019-10-22
• Device Publish Date: 2015-09-24

On-Brand Devices [NOVAL 0°]

• 04047844009376: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009369: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009352: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009345: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009338: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009321: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009314: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009307: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009291: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009284: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009277: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009260: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009253: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009246: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009239: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009222: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009215: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
• 04047844009208: The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK