Inertia® CONNEXX™ Modular Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Nexxt Spine Llc

Identity

Trade Name: Inertia® CONNEXX™ Modular Pedicle Screw System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Sterile Shank, Ø6.5x50mm FDA UDI
Model / Reference: 20-SDS-6550-SP FDA UDI
Description: Sterile Shank, Ø6.5x50mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00889929050804 FDA UDI
510(k) Number: K221905 FDA UDI
FDA Product Code: NKB FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 6.5 Millimeter FDA UDI
Length — 50 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

The Inertia CONNEXX Modular Pedicle Screw System is a non-bioabsorbable, sterile spinal bone screw designed for internal spinal fixation. It provides immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities.

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Cleared under the same submission

K221905 also covers:

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

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

Manufacturer

Manufacturer: Nexxt Spine Llc

Sources (1)

FDA UDI d6fb06ea-d16a-4c7e-b1b5-bfb7db482977 36 fields · synced Jul 8, 2026