CarboClear Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: CarboClear Pedicle Screw System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Navigated Pedicle Screw Screwdriver for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System. FDA UDI
Model / Reference: Navigated Screwdriver FDA UDI
Description: Navigated Pedicle Screw Screwdriver for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System. FDA UDI

Identifiers

Catalog Number: PPS922160N FDA UDI
Primary DI / UDI-DI: 07290110208417 FDA UDI
510(k) Number: K201251 FDA UDI
FDA Product Code: NKB FDA UDI
OLO FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
882.4560 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 screwdriver, reusable

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

Similar devices

Also classified as Surgical screwdriver, reusable.

Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
PERLA ® TL — Spineart · Class II
USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I

Cleared under the same submission

K201251 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 732a9684-0971-4081-b736-133df134b8fb 36 fields · synced Jun 1, 2026