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Axium™

FDA UDI

Class III (US FDA UDI)

by Spinal Modulation, Inc.

Identity

Trade Name
Axium™ FDA UDI
Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
Device Name
90cm SlimTip Implant Lead Kit FDA UDI
Model / Reference
MN10450-90A FDA UDI
Description
90cm SlimTip Implant Lead Kit FDA UDI

Identifiers

Catalog Number
MN10450-90A FDA UDI
Primary DI / UDI-DI
05415067025548 FDA UDI
PMA Number
P150004 FDA UDI
FDA Product Code
PMP FDA UDI
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 90 Centimeter FDA UDI

Axium™ by Spinal Modulation, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P150004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spinal Modulation, Inc.

Sources (1)

  • FDA UDI 49126fe8-5825-4e18-87e9-3be6c218a8da 39 fields · synced Jun 7, 2026