PressON

GUDID B6785201470

End Coupler

NEXUS SPINE, L.L.C.

Bone-screw internal spinal fixation system rod

• Primary Device ID: B6785201470
• NIH Device Record Key: 8c2af92e-fec7-430c-9842-ac34d5642aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PressON
• Version Model Number: 520147
• 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: true
• 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	B6785201470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133287

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

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: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [PressON]

• B6785202170: MIS Pedicle Screw 5.5mm x 35mm, Cannulated
• B6785202160: MIS Pedicle Screw 5.5mm x 30mm, Cannulated
• B6785202150: MIS Pedicle Screw 5.5mm x 25mm, Cannulated
• B6785201470: End Coupler
• B6785208930: LevelUP Rivet
• B6785208920: LevelUP Coupler, Right
• B6785208910: LevelUP Coupler, Left
• B6785208900: LevelUP Coupler, Straight
• B6785208890: LevelUP Rivet
• B6785208870: LevelUP Coupler, Right
• B6785208860: LevelUP Coupler, Left
• B6785208850: LevelUP Coupler, Straight
• B6785203050: Fixed Length Coupler 77.5mm
• B6785203030: Fixed Length Coupler 72.5mm
• B6785203010: Fixed Length Coupler 67.5mm
• B6785202990: Fixed Length Coupler 62.5mm
• B6785201610: End LevelUP Coupler, Right
• B6785201600: End LevelUP Coupler, Left
• B6785201590: End LevelUP Coupler, Straight