Identity
- Trade Name
- neon™ superior spine system FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- neon hook, straight, long FDA UDI
- Model / Reference
- CS 1418-02 FDA UDI
- Description
- neon hook, straight, long FDA UDI
Identifiers
- Catalog Number
- CS 1418-02 FDA UDI
- Primary DI / UDI-DI
- 04052536007431 FDA UDI
- 510(k) Number
- K113346 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook 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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Bone-screw internal spinal fixation system hook
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 hook.
- PERLA ® TL — Spineart · Class II
- Medyssey Spinal System - Deformity — Medyssey Co., Ltd. · Class II
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- 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
K113346 also covers:
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — Ulrich GmbH & Co. KG
- neon™ superior spine system — 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 dfaa62d0-22ca-41bd-b856-35ee3760639d 36 fields · synced Jun 1, 2026