CarboClear Cervical Cage / VBR System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: CarboClear Cervical Cage / VBR System FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for use before insertion of the implant into the intervertebral space, to assist in selection of correct implant dimensions and to verify implant position within the disc space, as applicable. FDA UDI
Model / Reference: Implant Trial H=6 FDA UDI
Description: A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for use before insertion of the implant into the intervertebral space, to assist in selection of correct implant dimensions and to verify implant position within the disc space, as applicable. FDA UDI

Identifiers

Catalog Number: PL940410 FDA UDI
Primary DI / UDI-DI: 07290110208981 FDA UDI
510(k) Number: K222874 FDA UDI
FDA Product Code: ODP FDA UDI
PLR FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Category: Spinal implant trial

CarboClear Cervical Cage / VBR System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ROI-A — Ldr Spine USA · Class II

Cleared under the same submission

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 8ac2b2cd-8035-4e3e-b338-1448cbb4ae8f 36 fields · synced Jun 6, 2026