Identity
- Trade Name
- AXIEM™ FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- SHUNT PK 9735650 NON INVASIVE EM INAV FDA UDI
- Model / Reference
- 9735650 FDA UDI
- Description
- SHUNT PK 9735650 NON INVASIVE EM INAV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169657694 FDA UDI
- 510(k) Number
- K001284 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system 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: Neurological stereotactic surgery system
Axiem™ by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K001284 also covers:
- AXIEM™ — MEDTRONIC NAVIGATION, INC.
- AxiEM™ — MEDTRONIC NAVIGATION, INC.
- AxiEM™ — MEDTRONIC NAVIGATION, INC.
- AxiEM™ — MEDTRONIC NAVIGATION, INC.
- AxiEM™ — MEDTRONIC NAVIGATION, INC.
- Fusion — MEDTRONIC NAVIGATION, INC.
- Fusion™ ENT Image Guidance System — MEDTRONIC NAVIGATION, INC.
- Fusion™ ENT Image Guidance System — MEDTRONIC NAVIGATION, INC.
- Fusion™ ENT Image Guidance System — MEDTRONIC NAVIGATION, INC.
- StealthStation® AXIEM™ System — MEDTRONIC NAVIGATION, 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 Navigation, Inc.
Sources (1)
- FDA UDI 1fe33dc7-ea57-42ec-9682-29b474641112 35 fields · synced Jun 8, 2026