Identity
- Trade Name
- VBR Omni™ vertebral body replacement FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- VBR Omni, Ø 22 mm, Höhe 19-29 mm, angle 4° FDA UDI
- Model / Reference
- CS 2250-22-194 FDA UDI
- Description
- VBR Omni, Ø 22 mm, Höhe 19-29 mm, angle 4° FDA UDI
Identifiers
- Catalog Number
- CS 2250-22-194 FDA UDI
- Primary DI / UDI-DI
- 04052536179053 FDA UDI
- 510(k) Number
- K012254 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Vertebral body prosthesis
VBR Omni™ vertebral body replacement by Ulrich GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vertebral body prosthesis.
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CHESAPEAKE® Stabilization System — K2M, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- FORTIFY — GLOBUS MEDICAL, INC. · Class II
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
- Cascadia™ Interbody System — K2M, INC. · Class II
Cleared under the same submission
K012254 also covers:
- ADDplus — Ulrich GmbH & Co. KG
- ADDplus™, ADD™, VBR™, topaz™ — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
- ADD™ anterior distraction device — Ulrich GmbH & Co. KG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ulrich GmbH & Co. KG
Sources (1)
- FDA UDI 5d3d4fd1-12dd-4dd0-8d96-fd5d1555304d 36 fields · synced Jun 1, 2026