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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
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Cannulated pedicle screw (oncology) FDA UDI
Model / Reference
Pedicle Screw - Cannulated FDA UDI
Description
Cannulated pedicle screw (oncology) FDA UDI

Identifiers

Catalog Number
PNNSC7540 FDA UDI
Primary DI / UDI-DI
07290110204952 FDA UDI
510(k) Number
K173487 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 40 Millimeter FDA UDI
Outer Diameter — 7.5 Millimeter FDA UDI

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

Cleared under the same submission

K173487 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 85ad2751-9a4c-4e7e-aa99-7e88eb9893dc 38 fields · synced May 31, 2026