Inertia® Pedicle Screw and Deformity Correxxion® System

Basic Information

• Brand Name: Inertia® Pedicle Screw and Deformity Correxxion® System
• Primary DI: 00889929010631
• Version / Model: 10-36-5530
• Company Name: NEXXT SPINE, LLC
• Labeler DUNS: 003489810
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-21
• Public Version: 2
• Public Version Date: 2024-08-02
• Public Version Status: Update
• Public Device Record Key: 3662b52a-a9ed-498b-bd4a-dd406a4c1c4b

Device Description

Prebent Rod, Line, Ø5.5x30 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease	Orthopedic	888.3070	2
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	888.3070	2
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	888.3070	2
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	888.3070	2
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65116	Bone-screw internal spinal fixation system rod	An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889929010631	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153453	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5.5	Millimeter
Length	30	Millimeter
Device Size Text, specify			Prebent, Line