CarboClear Cervical Systems

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: CarboClear Cervical Systems FDA UDI
Generic Name: Orthopaedic bone calliper FDA UDI
Device Name: Intended to assist in determining the required implant length during operation. FDA UDI
Model / Reference: Cervical Caliper FDA UDI
Description: Intended to assist in determining the required implant length during operation. FDA UDI

Identifiers

Catalog Number: PL940230 FDA UDI
Primary DI / UDI-DI: 07290110207229 FDA UDI
510(k) Number: K200883 FDA UDI
K222874 FDA UDI
FDA Product Code: ODP FDA UDI
PLR FDA UDI
KWQ FDA UDI
GMDN Term: Orthopaedic bone calliper 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: Orthopaedic bone calliper

CarboClear Cervical Systems by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone calliper.

Invictus — ALPHATEC SPINE, INC. · Class I
LEG LENGTH CALIPER ASSY — Zimmer, Inc. · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Novel — ALPHATEC SPINE, INC. · Class I
Cortera — Xtant Medical Holdings, Inc. · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
VerteFIT — Ldr Spine USA · Class I
Perfix™ MIS — CG MedTech Co., Ltd. · Class I

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 9776d209-6321-4b67-8988-7f0b079268d6 36 fields · synced May 30, 2026