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: Surgical mallet FDA UDI
Device Name: A surgical tool used with the Implant Trials, if required, to assist in Trial removal from the disc space. May also be used for implant extraction. Used in Cage surgeries FDA UDI
Model / Reference: Slap Hammer FDA UDI
Description: A surgical tool used with the Implant Trials, if required, to assist in Trial removal from the disc space. May also be used for implant extraction. Used in Cage surgeries FDA UDI

Identifiers

Catalog Number: PL940101 FDA UDI
Primary DI / UDI-DI: 07290117351253 FDA UDI
510(k) Number: K222874 FDA UDI
FDA Product Code: ODP FDA UDI
PLR FDA UDI
GMDN Term: Surgical mallet 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: Surgical mallet

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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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 c969fbc0-2bc3-4786-b7eb-54f5902fb96e 36 fields · synced Jun 1, 2026