PressON Pedicle Screw System

GUDID B678520885S0

LevelUP Coupler, Straight

NEXUS SPINE, L.L.C.

Bone-screw internal spinal fixation system rod

• Primary Device ID: B678520885S0
• NIH Device Record Key: 7f7ebf88-21e0-4ade-bb89-5819372f39f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PressON Pedicle Screw System
• Version Model Number: 520885S
• Company DUNS: 028137605
• Company Name: NEXUS SPINE, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B678520885S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233234

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [PressON Pedicle Screw System]

• B678520910S0: L-Coupler 80mm
• B6785209100: L-Coupler 80mm
• B678520909S0: L-Coupler 77.5mm
• B6785209090: L-Coupler 77.5mm
• B678520908S0: L-Coupler 75mm
• B6785209080: L-Coupler 75mm
• B678520907S0: L-Coupler 72.5mm
• B6785209070: L-Coupler 72.5mm
• B678520906S0: L-Coupler 70mm
• B6785209060: L-Coupler 70mm
• B678520905S0: L-Coupler 67.5mm
• B678520904S0: L-Coupler 65mm
• B678520903S0: L-Coupler 62.5mm
• B678520902S0: L-Coupler 60mm
• B678520901S0: L-Coupler 57mm
• B678520900S0: L-Coupler 54mm
• B678520899S0: L-Coupler 51mm
• B678520898S0: L-Coupler 48mm
• B678520897S0: L-Coupler 45mm
• B678520896S0: L-Coupler 42mm
• B678520895S0: L-Coupler 39mm
• B678520608S0: L-Coupler 36mm
• B678520607S0: L-Coupler 34mm
• B678520606S0: L-Coupler 32mm
• B678520605S0: L-Coupler 30mm
• B678520604S0: L-Coupler 28mm
• B678520603S0: L-Coupler 26mm
• B678520602S0: L-Coupler 24mm
• B678520601S0: L-Coupler 22mm
• B678520600S0: L-Coupler 20mm
• B678520599S0: L-Coupler 18mm
• B678520889S0: LevelUP Rivet
• B678520887S0: LevelUP Coupler, Right
• B678520886S0: LevelUP Coupler, Left
• B678520885S0: LevelUP Coupler, Straight
• B678520864S0: PressON Rivet