Solidity Vertebral Body Replacement UU041-01-1621

GUDID 00814386022286

Center piece, yellow, Ø 13mm, height 16-21.5mm, one fixed end cap, one variable end cap

Ulrich Medical Usa, Inc.

Vertebral body prosthesis, non-sterile

• Primary Device ID: 00814386022286
• NIH Device Record Key: 5cfa82e6-c6e1-49a8-bcc6-42d27653d9ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solidity Vertebral Body Replacement
• Version Model Number: UU041-01-1621
• Catalog Number: UU041-01-1621
• 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	00814386022286 [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

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

Moist Heat or Steam Sterilization

[00814386022286]

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