neon³ CT spinal stabilization

FDA UDI

Class II (US FDA UDI)

by Ulrich GmbH & Co. KG

Identity

Trade Name: neon³ CT spinal stabilization FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Screw, Ø 4.0 mm, length 12 mm FDA UDI
Model / Reference: CS 3903-40-12 FDA UDI
Description: Screw, Ø 4.0 mm, length 12 mm FDA UDI

Identifiers

Catalog Number: CS 3903-40-12 FDA UDI
Primary DI / UDI-DI: 04052536084241 FDA UDI
510(k) Number: K150650 FDA UDI
K161032 FDA UDI
FDA Product Code: NKG FDA UDI
KWP FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3075 FDA UDI
888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

MRI Safety

MR Conditional FDA UDI

Category: Spinal bone screw, non-bioabsorbable

neon³ CT spinal stabilization by Ulrich GmbH & Co. KG — 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: Ulrich GmbH & Co. KG

Sources (1)

FDA UDI 5a3edea8-3d29-4a24-9fde-e758f0e516f8 36 fields · synced May 30, 2026