Identity
- Trade Name
- VERTEX® Reconstruction System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- BIT NAV2076 VERT STERILE DRILL BIT 2.9MM FDA UDI
- Model / Reference
- NAV2076 FDA UDI
- Description
- BIT NAV2076 VERT STERILE DRILL BIT 2.9MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169518414 FDA UDI
- 510(k) Number
- K143628 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
- Outer Diameter — 2.9 Millimeter FDA UDI
Category: Fluted surgical drill bit, single-use
VERTEX® Reconstruction System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143628 also covers:
- VERTEX® Reconstruction System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTEX® Reconstruction System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTEX® Reconstruction System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTEX® Reconstruction System — MEDTRONIC SOFAMOR DANEK, INC.
- VERTEX® Reconstruction System — MEDTRONIC SOFAMOR DANEK, INC.
- Vertex Select — 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 2798807c-0c18-4322-b22d-c5df938bfb68 36 fields · synced May 30, 2026