obeliscPRO™ vertebral body replacement CS 2916-10

GUDID 04052536113804

obelisc lateral end piece, blue, length 55 mm, angle 10°

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: 04052536113804
• NIH Device Record Key: 36b65f3b-6d3e-43a8-9a24-490aca6b78c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: obeliscPRO™ vertebral body replacement
• Version Model Number: CS 2916-10
• Catalog Number: CS 2916-10
• 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	04052536113804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060416

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

Moist Heat or Steam Sterilization

[04052536113804]

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 [obeliscPRO™ vertebral body replacement]

• 04052536162963: Shaft flexible for screwdriver, hex 3.5 mm
• 04052536162956: Locking rod flexible, length 450 mm
• 04052536162949: Expansion rod flexible, length 450 mm
• 04052536162932: Holder curved, length 450 mm
• 04052536113811: obelisc lateral end piece, blue, length 55 mm, angle 15°
• 04052536113804: obelisc lateral end piece, blue, length 55 mm, angle 10°
• 04052536113798: obelisc lateral end piece, blue, length 55 mm, angle 5°
• 04052536113781: obelisc lateral end piece, blue, length 55 mm, angle 0°
• 04052536113774: obelisc lateral end piece, green, length 45 mm, angle 15°
• 04052536113767: obelisc lateral end piece, green, length 45 mm, angle 10°
• 04052536113750: obelisc lateral end piece, green, length 45 mm, angle 5°
• 04052536113743: obelisc lateral end piece, green, length 45 mm, angle 0°
• 04052536113736: obelisc lateral end piece, yellow, length 35 mm, angle 15°
• 04052536113729: obelisc lateral end piece, yellow, length 35 mm, angle 10°
• 04052536113712: obelisc lateral end piece, yellow, length 35 mm, angle 5°
• 04052536113705: obelisc lateral end piece, yellow, length 35 mm, angle 0°