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Inertia® MIS Pedicle Screw System

FDA UDI

Class I (US FDA UDI)

by Nexxt Spine Llc

Identity

Trade Name
Inertia® MIS Pedicle Screw System FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
K-Wire, SST, Trocar Tip, Threaded, Ø1.4x590 FDA UDI
Model / Reference
I10-14-294 FDA UDI
Description
K-Wire, SST, Trocar Tip, Threaded, Ø1.4x590 FDA UDI

Identifiers

Primary DI / UDI-DI
00889929018842 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 590 Millimeter FDA UDI
Outer Diameter — 1.4 Millimeter FDA UDI

Category: General internal orthopaedic fixation system implantation kit

Inertia® MIS Pedicle Screw System by Nexxt Spine Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nexxt Spine Llc

Sources (1)

  • FDA UDI 12d33c4b-f6b6-4c42-a6c8-b2f7a407de21 35 fields · synced May 31, 2026