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Inertia® Pedicle Screw and Deformity Correxxion® System

FDA UDI

Class II (US FDA UDI)

by Nexxt Spine Llc

Identity

Trade Name
Inertia® Pedicle Screw and Deformity Correxxion® System FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Hook Impactor FDA UDI
Model / Reference
I10-23-04 FDA UDI
Description
Hook Impactor FDA UDI

Identifiers

Primary DI / UDI-DI
00889929022900 FDA UDI
510(k) Number
K090984 FDA UDI
FDA Product Code
MNH FDA UDI
MNI FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 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

No

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

Category: General internal orthopaedic fixation system implantation kit

Inertia® Pedicle Screw and Deformity Correxxion® System by Nexxt Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Cleared under the same submission

K090984 also covers:

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 5f6c0564-b497-43dc-9c4d-495fc2ace175 35 fields · synced May 31, 2026