obelisc™ vertebral body replacement CS 2914-10

GUDID 04052536198672

obelisc lateral end piece, yellow, length 35 mm, angle 10°

Ulrich GmbH & Co. KG

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: 04052536198672
• NIH Device Record Key: 11f6f2d4-0a09-4e29-ae8d-0c594fba173a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: obelisc™ vertebral body replacement
• Version Model Number: CS 2914-10
• Catalog Number: CS 2914-10
• 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: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536113729 [Previous]
GS1	04052536198672 [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

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

[04052536198672]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-11
• Device Publish Date: 2022-11-03

On-Brand Devices [obelisc™ vertebral body replacement]

• 04052536113699: obelisc locking screw short, hex 3.5 mm
• 04052536013661: obelisc end piece, bronze, oval, 32x26 mm, angle 20°
• 04052536013654: obelisc end piece, bronze, oval, 32x26 mm, angle 15°
• 04052536013647: obelisc end piece, bronze, oval, 32x26 mm, angle 10°
• 04052536013630: obelisc end piece, bronze, oval, 32x26 mm, angle 5°
• 04052536013623: obelisc end piece, bronze, oval, 32x26 mm, angle 0°
• 04052536013616: obelisc end piece, blue, Ø 32 mm, angle 15°
• 04052536013609: obelisc end piece, blue, Ø 32 mm, angle 10°
• 04052536013593: obelisc end piece, blue, Ø 32 mm, angle 5°
• 04052536013586: obelisc end piece, blue, Ø 32 mm, angle 0°
• 04052536013579: obelisc end piece, green, Ø 29 mm, angle 15°
• 04052536013562: obelisc end piece, green, Ø 29 mm, angle 10°
• 04052536013555: obelisc end piece, green, Ø 29 mm, angle 5°
• 04052536013548: obelisc end piece, green, Ø 29 mm, angle 0°
• 04052536013531: obelisc end piece, yellow, Ø 26 mm, angle 15°
• 04052536013524: obelisc end piece, yellow, Ø 26 mm, angle 10°
• 04052536013517: obelisc end piece, yellow, Ø 26 mm, angle 5°
• 04052536013500: obelisc end piece, yellow, Ø 26 mm, angle 0°
• 04052536013494: obelisc end piece, light blue, Ø 24 mm, angle 15°
• 04052536013487: obelisc end piece, light blue, Ø 24 mm, angle 10°
• 04052536013470: obelisc end piece, light blue, Ø 24 mm, angle 5°
• 04052536013463: obelisc end piece, light blue, Ø 24 mm, angle 0°
• 04052536013456: obelisc end piece, grey, Ø 20 mm, angle 15°
• 04052536013449: obelisc end piece, grey, Ø 20 mm, angle 10°
• 04052536013432: obelisc end piece, grey, Ø 20 mm, angle 5°
• 04052536013425: obelisc end piece, grey, Ø 20 mm, angle 0°
• 04052536013418: obelisc center piece, Ø 20 mm, height 27-38 mm two variable end pieces
• 04052536013401: obelisc center piece, ø 20 mm, height 23-31 mm two variable end pieces
• 04052536013395: obelisc center piece, ø 20 mm, height 17-23 mm two fix end pieces
• 04052536013388: Spring for obelisc end piece
• 04052536005727: obelisc end piece, oval, 32 x 26 mm, angle 15°
• 04052536005710: obelisc end piece, Ø 26 mm, angle 10°
• 04052536005703: obelisc end piece, Ø 26 mm, angle 5°
• 04052536005697: obelisc end piece, Ø 26 mm, angle 0°
• 04052536005680: obelisc end piece, Ø 24 mm, angle 10°
• 04052536005673: obelisc end piece, Ø 24 mm, angle 5°
• 04052536005666: obelisc end piece, Ø 24 mm, angle 0°
• 04052536005659: obelisc end piece, Ø 20 mm, angle 10°
• 04052536005642: obelisc end piece, Ø 20 mm, angle 5°
• 04052536005635: obelisc end piece, Ø 20 mm, angle 0°
• 04052536005628: obelisc center piece, ø 20 mm, height 76-132 mm two variable end pieces
• 04052536005611: obelisc center piece, ø 20 mm, height 53-87 mm two variable end pieces
• 04052536005604: obelisc center piece, ø 20 mm, height 40-62 mm two variable end pieces
• 04052536005598: obelisc center piece, ø 20 mm, height 32-47 mm two variable end pieces
• 04052536005581: obelisc center piece, Ø 20 mm, height 25-37 mm one fix end piece, one variable end piece
• 04052536005574: obelisc center piece, ø 20 mm, height 20-28 mm one fix end piece, one variable end piece
• 04052536005567: obelisc locking screw
• 04052536198818: Shaft flexible for screwdriver, hex 3.5 mm
• 04052536198795: Locking rod flexible, length 450 mm
• 04052536198788: Expansion rod flexible, length 450 mm