Omnia Medical VBR

FDA UDI

Class II (US FDA UDI)

by Omnia Medical

Identity

Trade Name: Omnia Medical VBR FDA UDI
Generic Name: Vertebral body prosthesis, non-sterile FDA UDI
Device Name: Omnia Medical VBR, 12mm X 12.5mm X 13mm Tall FDA UDI
Model / Reference: 06-0V-1213 FDA UDI
Description: Omnia Medical VBR, 12mm X 12.5mm X 13mm Tall FDA UDI

Identifiers

Catalog Number: 06-0V-1213 FDA UDI
Primary DI / UDI-DI: 00843511100001 FDA UDI
510(k) Number: K172323 FDA UDI
FDA Product Code: MQP FDA UDI
GMDN Term: Vertebral body prosthesis, non-sterile 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 13 Millimeter FDA UDI
Depth — 12.5 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI

Category: Vertebral body prosthesis, non-sterile

Omnia Medical VBR by Omnia Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body prosthesis, non-sterile.

L-Box® — Innovasis, Inc. · Class II
Zavation — ZAVATION · Class II
Medyssey Poseidon OCT Spinal Fixation System — Medyssey Co., Ltd. · Class II
Medyssey Poseidon OCT Spinal Fixation System — Medyssey Co., Ltd. · Class II
Vu aPod™ - L — SeaSpine Orthopedics Corporation · Class II
HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Apache — Genesys Orthopedics Systems LLC · Class II
SeaSpine Spacer System - Redondo™ — SeaSpine Orthopedics Corporation · Class II

Cleared under the same submission

K172323 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Omnia Medical

Sources (1)

FDA UDI 3f3d188a-f649-44a4-bdf1-42c0b69d17e2 37 fields · synced Jun 8, 2026