A8 INTEGR8® Porous Pedicle Screw System

Basic Information

• Brand Name: A8 INTEGR8® Porous Pedicle Screw System
• Primary DI: 10850062071213
• Version / Model: A8-65-0060
• Catalog Number: A8-65-0060
• Company Name: ALLUMIN8, INC.
• Labeler DUNS: 121774080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2026-02-27
• Public Version: 1
• Public Version Date: 2026-03-09
• Public Version Status: New
• Public Device Record Key: d31ad1a4-fff6-42b3-8ef2-ba81f094b7ab

Device Description

A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw Ø6.5x60mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850062071216	GS1
Primary	10850062071213	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K242827	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	6.5	Millimeter
Length	60	Millimeter