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Nim-Spine

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K031510

by Medtronic Xomed

Identity

Trade Name
NIM-Spine® FDA UDI
Generic Name
Subdermal needle electrode FDA UDI
Device Name
ELECTRODE 8227702E LOW IMP NDL 22MM ROHS FDA UDI
Model / Reference
8227702E FDA UDI
Description
ELECTRODE 8227702E LOW IMP NDL 22MM ROHS FDA UDI

Identifiers

Primary DI / UDI-DI
00643169314429 FDA UDI
510(k) Number
K031510 FDA 510(k)FDA UDI
FDA Product Code
ETN FDA 510(k)FDA UDI
GWF FDA UDI
IKN FDA UDI
GMDN Term
Subdermal needle electrode FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 874.1820 FDA 510(k)
Regulation Number
874.1820 FDA 510(k)FDA UDI
882.1870 FDA UDI
890.1375 FDA UDI
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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
Length — 22.0 Millimeter FDA UDI

Nim-Spine by Medtronic Xomed — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Xomed

Sources (2)

  • FDA 510(k) K031510 24 fields · synced Jun 18, 2026
  • FDA UDI e074dd83-02fc-4d1b-bfb8-47b4243b5a85 36 fields · synced May 26, 2026