Identity
- Trade Name
- MSB VERTE-STACK Spinal System FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- INSTRUMENT 3289400 INSERTER HANDLE FDA UDI
- Model / Reference
- 3289400 FDA UDI
- Description
- INSTRUMENT 3289400 INSERTER HANDLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885074036175 FDA UDI
- 510(k) Number
- K090353 FDA UDI
- FDA Product Code
- MAX FDA UDIMQP FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI888.3060 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: Surgical instrument handle, non-torque-limiting
MSB VERTE-STACK Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument handle, non-torque-limiting.
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- Tecomet — Tecomet,Inc · Class I
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- CUSTOM U JOINT DRIVER — Zimmer, Inc. · Class I
Cleared under the same submission
K090353 also covers:
- CATALYST® Reusable Instruments — 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.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — MEDTRONIC SOFAMOR DANEK, INC.
- PERIMETER® Interbody Fusion Device — 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 d4faa34c-3d9f-4abc-aeda-f455b53655d1 35 fields · synced Jun 8, 2026