← Back to catalogue
neon³
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref CS 3910-01-080-SModel Rod, sterile
Identity
- Trade Name
- neon³ EUDAMED
- Model / Reference
- Rod, sterile EUDAMEDCS 3910-01-080-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04052536209767 EUDAMED
- Basic UDI-DI
- 4052536000104PR EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Cervical spine immobilization system, single-use
neon³ by ulrich GmbH & Co. KG — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Cervical spine immobilization system, single-use.
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- SKYLINE ANTERIOR CERVICAL PLATE SYSTEM — MEDOS INTERNATIONAL SARL · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- SYMPHONY OCT SYSTEM — MEDOS INTERNATIONAL SARL · Class IIb
- MATRIS - Cervical plates and screw — NovaSpine · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150650 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4052536000104PR | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ulrich GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006411
Sources (2)
- EUDAMED e4c50589-32c0-4531-89b2-8b02e4a007b9 61 fields · synced Oct 7, 2026
- FDA 510(k) K150650 1 fields · synced May 18, 2026