Preference

FDA UDI

Class II (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name: PREFERENCE FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: 4.5mm Polyaxial Screw Reduction 30mm Magenta FDA UDI
Model / Reference: 28-4501-030 FDA UDI
Description: 4.5mm Polyaxial Screw Reduction 30mm Magenta FDA UDI

Identifiers

Primary DI / UDI-DI: 00841732151789 FDA UDI
510(k) Number: K081296 FDA UDI
FDA Product Code: KWQ FDA UDI
KWP FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
888.3050 FDA UDI
888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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: Spinal bone screw, non-bioabsorbable

Preference by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Spinal bone screw, non-bioabsorbable.

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ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

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 d6ff7889-975b-4e1f-9c06-8b4db6c27fa3 35 fields · synced May 30, 2026