Identity
- Trade Name
- neon³ CT spinal stabilization FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Rod, titanium alloy, Ø 4.0 mm, length 240 mm, with hex end FDA UDI
- Model / Reference
- CS 3910-240 FDA UDI
- Description
- Rod, titanium alloy, Ø 4.0 mm, length 240 mm, with hex end FDA UDI
Identifiers
- Catalog Number
- CS 3910-240 FDA UDI
- Primary DI / UDI-DI
- 04052536084838 FDA UDI
- 510(k) Number
- K150650 FDA UDI
- FDA Product Code
- KWP FDA UDINKG FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3075 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Bone-screw internal spinal fixation system rod
neon³ CT spinal stabilization 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 rod.
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
Cleared under the same submission
K150650 also covers:
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
- neon³ CT spinal stabilization — Ulrich GmbH & Co. KG
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 7a570865-e664-4052-8df1-e40d160f8ee1 36 fields · synced May 31, 2026