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CarboClear Posterior Cervical Screw System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name
CarboClear Posterior Cervical Screw System FDA UDI
Generic Name
Bone tap, reusable FDA UDI
Device Name
Bone Tap for use with the CarboClear Posterior Cervical Screw System FDA UDI
Model / Reference
Bone Tap FDA UDI
Description
Bone Tap for use with the CarboClear Posterior Cervical Screw System FDA UDI

Identifiers

Catalog Number
CS016 FDA UDI
Primary DI / UDI-DI
07290117351062 FDA UDI
510(k) Number
K233989 FDA UDI
FDA Product Code
NKG FDA UDI
ODP FDA UDI
GMDN Term
Bone tap, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3075 FDA UDI
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.0 Millimeter FDA UDI

Category: Bone tap, reusable

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

Similar devices

Also classified as Bone tap, reusable.

Cleared under the same submission

K233989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carbofix Orthopedics Ltd

Sources (1)

  • FDA UDI 41e6dbec-cae0-444f-bdf7-14e7ed27ef55 37 fields · synced Jun 8, 2026