Identity
- Trade Name
- neon³™ OCT spinal stabilization FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- Crosslink, screw to screw, L FDA UDI
- Model / Reference
- CS 3917-10 FDA UDI
- Description
- Crosslink, screw to screw, L FDA UDI
Identifiers
- Catalog Number
- CS 3917-10 FDA UDI
- Primary DI / UDI-DI
- 04052536161621 FDA UDI
- 510(k) Number
- K161032 FDA UDI
- FDA Product Code
- NKG FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3075 FDA UDI888.3050 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Bone-screw internal spinal fixation system connector
neon³™ OCT 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 connector.
- Arsenal — ALPHATEC SPINE, INC. · Class II
- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
Cleared under the same submission
K161032 also covers:
- NEON 3 — Ulrich GmbH & Co. KG
- NEON 3 — Ulrich GmbH & Co. KG
- NEON 3 — Ulrich GmbH & Co. KG
- NEON 3 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ulrich GmbH & Co. KG
Sources (1)
- FDA UDI dc3f0c04-683b-43d5-aef7-e440aec2f60f 36 fields · synced May 31, 2026