PREFERENCE Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name: PREFERENCE Pedicle Screw System FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: Connector Caddy- Fixed FDA UDI
Model / Reference: 055.8108 FDA UDI
Description: Connector Caddy- Fixed FDA UDI

Identifiers

Primary DI / UDI-DI: 00841732145139 FDA UDI
510(k) Number: K081296 FDA UDI
FDA Product Code: KWP FDA UDI
KWQ FDA UDI
MNI FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3060 FDA UDI
888.3070 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

PREFERENCE Pedicle Screw System by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Instrument Case — Katena Products, Inc. · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
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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: CTL Medical Corporation

Sources (1)

FDA UDI 747150cb-08f1-421e-b291-a89ab6863f03 35 fields · synced Jun 1, 2026