Identity
- Trade Name
- CD HORIZON® Spinal System FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- MESH X0507159 ELLIPTICAL 10X25X12 FDA UDI
- Model / Reference
- X0507159 FDA UDI
- Description
- MESH X0507159 ELLIPTICAL 10X25X12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994351364 FDA UDI
- FDA Product Code
- MQP FDA UDIMAX FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3080 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
Dimensions & Sizes
- Size
- Length — 25.0 Millimeter FDA UDIHeight — 10.0 Millimeter FDA UDI
Category: Vertebral body prosthesis
CD HORIZON® Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K011406 also covers:
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
- PYRAMESH® C Titanium Mesh — MEDTRONIC SOFAMOR DANEK, INC.
K110562 also covers:
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- MSB TELAMON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- MSB TELAMON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- MSB TELAMON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- MSB TELAMON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- MSB TELAMON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 8d8bffc7-3bb8-4ec6-aecd-8c85702e6f28 36 fields · synced May 31, 2026