CarboClear Vertebral Body Replacement System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: CarboClear Vertebral Body Replacement System FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: A spinal vertebral body replacement device FDA UDI
Model / Reference: VBR Spacer FDA UDI
Description: A spinal vertebral body replacement device FDA UDI

Identifiers

Catalog Number: VBR2722065 FDA UDI
Primary DI / UDI-DI: 07290110205850 FDA UDI
510(k) Number: K192214 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 65 Millimeter FDA UDI
Outer Diameter — 27 Millimeter FDA UDI
Outer Diameter — 22 Millimeter FDA UDI

Category: Vertebral body prosthesis

CarboClear Vertebral Body Replacement System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body prosthesis.

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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

K192214 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

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Manufacturer

Manufacturer: Carbofix Orthopedics Ltd

Sources (1)

FDA UDI 9ebf1304-12a8-43ef-b8f4-c3a9f028865b 37 fields · synced May 30, 2026