Identity
- Trade Name
- VERTE-STACK® FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- SPACER 6287941 PSR LAT PORTS 9X14X11 FDA UDI
- Model / Reference
- 6287941 FDA UDI
- Description
- SPACER 6287941 PSR LAT PORTS 9X14X11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000857561 FDA UDI
- 510(k) Number
- K052931 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
Yes
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
Dimensions & Sizes
- Size
- Height — 14.0 Millimeter FDA UDIWidth — 9.0 Millimeter FDA UDIDepth — 11.0 Millimeter FDA UDI
Category: Vertebral body prosthesis
Verte-Stack® 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.
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- CASCADIA™ Interbody System — K2M, INC. · Class II
- FORTIFY — GLOBUS MEDICAL, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
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- Novel — ALPHATEC SPINE, INC. · Class II
Cleared under the same submission
K052931 also covers:
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTE-STACK® 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 3dc6eee8-1c5a-4ee5-9e10-5302f9c11b70 36 fields · synced May 29, 2026