Identity
- Trade Name
- T2™ Spinal System FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- END CAP 9401600 16MM 0 DEGREE FDA UDI
- Model / Reference
- 9401600 FDA UDI
- Description
- END CAP 9401600 16MM 0 DEGREE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994676177 FDA UDI
- 510(k) Number
- K131888 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
Dimensions & Sizes
- Size
- Angle — 0.0 degree FDA UDIOuter Diameter — 16.0 Millimeter FDA UDI
Category: Vertebral body prosthesis
T2™ Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vertebral body prosthesis.
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CHESAPEAKE® Stabilization System — K2M, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- FORTIFY — GLOBUS MEDICAL, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
- Cascadia™ Interbody System — K2M, INC. · Class II
- Novel — ALPHATEC SPINE, INC. · Class II
Cleared under the same submission
K131888 also covers:
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- T2™ 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 b7fecf66-6a17-46d1-9a3a-80da72c3d9c7 36 fields · synced Jun 8, 2026