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neon™ superior spine system

FDA UDI

Class II (US FDA UDI)

by Ulrich GmbH & Co. KG

Identity

Trade Name
neon™ superior spine system FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
neon hex nut for easy fit, gold FDA UDI
Model / Reference
CS 1411-4T FDA UDI
Description
neon hex nut for easy fit, gold FDA UDI

Identifiers

Catalog Number
CS 1411-4T FDA UDI
Primary DI / UDI-DI
04052536003396 FDA UDI
510(k) Number
K113346 FDA UDI
FDA Product Code
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

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

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Bone-screw internal spinal fixation system connector

neon™ superior spine system by Ulrich GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K113346 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ulrich GmbH & Co. KG

Sources (1)

  • FDA UDI 7baaa9da-3de7-4b3b-93cc-2da36ed1a6c8 36 fields · synced Jun 1, 2026