NIM-Spine®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: NIM-Spine® FDA UDI
Generic Name: Subdermal needle electrode FDA UDI
Device Name: ELECTRODE 8227702E LOW IMPED NEEDLE 22MM FDA UDI
Model / Reference: 8227702E FDA UDI
Description: ELECTRODE 8227702E LOW IMPED NEEDLE 22MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994896728 FDA UDI
510(k) Number: K031510 FDA UDI
FDA Product Code: ETN FDA UDI
IKN FDA UDI
GWF FDA UDI
GMDN Term: Subdermal needle electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 FDA UDI
890.1375 FDA UDI
882.1870 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 22.0 Millimeter FDA UDI

Category: Subdermal needle electrode

NIM-Spine® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subdermal needle electrode.

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Neuroradium — Technomed Engineering B.V. · Class II
Sphenoidal Electrode Set — Ad-Tech Medical Instrument Corp. · Class II
Spinal Electrode Kit — Ad-Tech Medical Instrument Corp. · Class II
Horizon™ — Advantage Medical Electronics, LLC · Class II
Neuroline SubdermalNeurology Needle Electrodes — Ambu A/S · Class II

Cleared under the same submission

K031510 also covers:

NIM9Spine — 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 Xomed, Inc.

Sources (1)

FDA UDI 205f1837-1bd6-40b6-b206-caee9a3a09c9 36 fields · synced May 30, 2026