Identity
- Trade Name
- SOVEREIGN™ Spinal System FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- SPACER 78671816 SV PTC S 32X23X16 18D CP FDA UDI
- Model / Reference
- 78671816 FDA UDI
- Description
- SPACER 78671816 SV PTC S 32X23X16 18D CP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169658882 FDA UDI
- 510(k) Number
- K172328 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 16.0 Millimeter FDA UDILength — 32.0 Millimeter FDA UDIWidth — 23.0 Millimeter FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
SOVEREIGN™ Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-polymer composite spinal interbody fusion cage.
- Battalion Universal Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- Irix-A Lumbar Integrated Fusion System — Xtant Medical Holdings, Inc. · Class II
- Tyber Medical — Tyber Medical · Class II
- Reef TA — SeaSpine Orthopedics Corporation · Class II
- ROI-C — Ldr Spine USA · Class II
- LUCENT XP ARC — SPINAL ELEMENTS, INC. · Class II
- Shoreline ACS — SeaSpine Orthopedics Corporation · Class II
- MIDLINE II-Ti — Centinel Spine, LLC · Class II
Cleared under the same submission
K172328 also covers:
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ 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 015685d8-5106-41f3-b437-90c0c96a6fee 36 fields · synced May 30, 2026