Identity
- Trade Name
- neon³ CT spinal stabilization FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Hook, straight, short FDA UDI
- Model / Reference
- CS 3916-01 FDA UDI
- Description
- Hook, straight, short FDA UDI
Identifiers
- Catalog Number
- CS 3916-01 FDA UDI
- Primary DI / UDI-DI
- 04052536085033 FDA UDI
- 510(k) Number
- K150650 FDA UDI
- FDA Product Code
- NKG FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook 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 hook
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 hook.
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- PASS LP PASS TL — Medicrea International SA · Class II
- DENALI® Spinal System — K2M, INC. · Class II
- MESA® Small Stature Spinal System — K2M, INC. · Class II
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- ReLine — Nuvasive, 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 c015f9f4-c2bb-4b61-a94f-ba2bf2382712 36 fields · synced May 30, 2026