RABEA 0° PK051212

GUDID 04047844000434

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.

SIGNUS Medizintechnik GmbH

Polymeric spinal fusion cage, sterile

• Primary Device ID: 04047844000434
• NIH Device Record Key: bcdc15cd-1ab5-4c18-84e2-67e3848162e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RABEA 0°
• Version Model Number: Cervical cage, straight
• Catalog Number: PK051212
• 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	04047844000434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082848

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

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: 2019-10-23
• Device Publish Date: 2015-09-24

On-Brand Devices [RABEA 0°]

• 04047844000588: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000571: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000564: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000557: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000540: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000533: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000526: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000519: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000502: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000496: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000489: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000472: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000465: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000458: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000441: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000434: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000427: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000410: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000403: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000335: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000328: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000311: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000304: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000298: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000281: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000274: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000267: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000250: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000243: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000236: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000229: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000212: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000205: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000199: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000106: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000090: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000083: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000076: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000069: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000052: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000045: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000038: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000021: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
• 04047844000014: The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec