Identity
- Trade Name
- CD HORIZON® Spinal System FDA UDI
- Generic Name
- Orthopaedic joint/limb rongeur FDA UDI
- Device Name
- TAP X1013182 7.5MM SOLID FDA UDI
- Model / Reference
- X1013182 FDA UDI
- Description
- TAP X1013182 7.5MM SOLID FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169465855 FDA UDI
- 510(k) Number
- K143019 FDA UDI
- FDA Product Code
- MNH FDA UDIKWP FDA UDIKWQ FDA UDIOSH FDA UDINKB FDA UDIMNI FDA UDIHWE FDA UDI
- GMDN Term
- Orthopaedic joint/limb rongeur FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI888.3060 FDA UDI878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Orthopaedic joint/limb rongeur
CD HORIZON® Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic joint/limb rongeur.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Sklar® — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Sklar® — Sklar Corporation · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- MICRO FRIEDMAN RONGEUR — SONTEC INSTRUMENTS, INC. · Class I
- Sklar® — Sklar Corporation · Class I
Cleared under the same submission
K143019 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.
- 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.
- 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.
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 53e0df08-243a-4773-98f0-3fc06366c0c8 36 fields · synced May 30, 2026