Ingenix

GUDID 00843672101633

Polyax def screw 7.5x80mm for 5.5 rod

INGENIUMSPINE, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00843672101633
• NIH Device Record Key: 50aa64fd-6bd7-4f46-bef4-8e8ca3ead412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingenix
• Version Model Number: 55027580
• Company DUNS: 082805471
• Company Name: INGENIUMSPINE, LLC
• 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: false
• 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
GS1	00843672101633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173126

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00843672101633]

Moist Heat or Steam Sterilization

[00843672101633]

Moist Heat or Steam Sterilization

[00843672101633]

Moist Heat or Steam Sterilization

[00843672101633]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-23
• Device Publish Date: 2022-05-14

On-Brand Devices [Ingenix]

• 00843672101657: Polyax screw 7.5x80mm for 5.5 rod
• 00843672101640: Polyax screw 7.5x70mm for 5.5 rod
• 00843672101633: Polyax def screw 7.5x80mm for 5.5 rod
• 00843672101626: Polyax def screw 7.5x75mm for 5.5 rod
• 00843672101619: Polyax def screw 7.5x70mm for 5.5 rod
• 00843672101602: Polyax def screw 7.5x65mm for 5.5 rod
• 00843672101596: Polyax DEF Screw 7.5x60mm for 5.5mm Rod