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Navigated INFINITY™ Occipitocervical Upper Thoracic System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Navigated INFINITY™ Occipitocervical Upper Thoracic System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- DRILL BIT NAVG3606010 NAVIGATED FDA UDI
- Model / Reference
- NAVG3606010 FDA UDI
- Description
- DRILL BIT NAVG3606010 NAVIGATED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169799936 FDA UDI
- 510(k) Number
- K181111 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
Category: Fluted surgical drill bit, single-use
Navigated INFINITY™ Occipitocervical Upper Thoracic System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID
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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 43d1a206-110d-49a4-96d1-0f16a3e312be 35 fields · synced May 29, 2026