ADDplus™ anterior distraction device plus CS 2253-12-13

GUDID 04052536009350

ADDplus, ø 12 mm, height 13-18 mm, angle 0°

Ulrich GmbH & Co. KG

Vertebral body prosthesis, non-sterile Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 04052536009350
• NIH Device Record Key: 0e616caa-69c8-4fb6-bf2c-dd1b0882e478
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADDplus™ anterior distraction device plus
• Version Model Number: CS 2253-12-13
• Catalog Number: CS 2253-12-13
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• 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: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536009350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090841

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

[04052536009350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-30

On-Brand Devices [ADDplus™ anterior distraction device plus]

• 04052536009381: ADDplus, ø 12 mm, height 40-65 mm, angle 18°
• 04052536009374: ADDplus, ø 12 mm, height 25-41 mm, angle 12°
• 04052536009367: ADDplus, ø 12 mm, height 17-26 mm, angle 6°
• 04052536009350: ADDplus, ø 12 mm, height 13-18 mm, angle 0°