Solidity Vertebral Body Replacement UU041-02-1300

GUDID 00814386022347

End cap, Ø 13mm, 0°

Ulrich Medical Usa, Inc.

Vertebral body prosthesis, non-sterile 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: 00814386022347
• NIH Device Record Key: a72977e1-0f33-4c0a-b943-578c359ce0a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solidity Vertebral Body Replacement
• Version Model Number: UU041-02-1300
• Catalog Number: UU041-02-1300
• Company DUNS: 624083866
• Company Name: Ulrich Medical Usa, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 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: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com
• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814386022347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181921

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

[00814386022347]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-28
• Device Publish Date: 2018-12-27

On-Brand Devices [Solidity Vertebral Body Replacement]

• 00814386022668: End cap caddy, lid
• 00814386022651: End cap caddy
• 00814386022644: Center piece caddy
• 00814386022637: Outer tray, lid
• 00814386022620: Outer tray, base
• 00814386022613: Tamper
• 00814386022606: Adjustor
• 00814386022590: Star grip handle, for expansion rod
• 00814386022583: Expansion rod, for inserter
• 00814386022569: Inner shaft, for inserter
• 00814386022552: Holder, for inserter
• 00814386022545: Mallet
• 00814386022538: Detachment handle, metal
• 00814386022521: Attachment handle, plastic
• 00814386022514: Assembly block
• 00814386022507: Lollipop trial, 16x13mm and 19x16mm
• 00814386022491: Lollipop trial, Ø 13mm and Ø 16mm
• 00814386022484: Sliding arm, for measuring gauge
• 00814386022477: Handle, for measuring gauge
• 00814386022460: Extension ring, Ø 16mm, 0°
• 00814386022453: End cap, oval, 19x16mm, 10°
• 00814386022446: End cap, oval, 19x16mm, 5°
• 00814386022439: End cap, oval, 19x16mm, 0°
• 00814386022422: End cap, oval, 16x13mm, 10°
• 00814386022415: End cap, oval, 16x13mm, 5°
• 00814386022408: End cap, oval, 16x13mm, 0°
• 00814386022392: End cap, Ø 16mm, 10°
• 00814386022385: End cap, Ø 16mm, 5°
• 00814386022378: End cap, Ø 16mm, 0°
• 00814386022361: End cap, Ø 13mm, 10°
• 00814386022354: End cap, Ø 13mm, 5°
• 00814386022347: End cap, Ø 13mm, 0°
• 00814386022330: Center piece, bronze, Ø 13mm, height 47-72mm, two variable end caps
• 00814386022323: Center piece, blue, Ø 13mm, height 35-51mm, two variable end caps
• 00814386022316: Center piece, green, Ø 13mm, height 28-39mm, two variable end caps
• 00814386022309: Center piece, magenta, Ø 13mm, height 24-32mm, two variable end caps
• 00814386022293: Center piece, turquoise, Ø 13mm, height 19-27.5mm, one fixed end cap, one variable end cap
• 00814386022286: Center piece, yellow, Ø 13mm, height 16-21.5mm, one fixed end cap, one variable end cap
• 00814386022279: Center piece, light blue, Ø 13mm, height 13-17.5mm, two fixed end caps