ARx SAI

GUDID 00190837175191

Life Spine, Inc.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00190837175191
• NIH Device Record Key: 47aeac88-1c49-4e8e-bf8d-b8dc2fe26578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARx SAI
• Version Model Number: 18-8580-09
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• 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	00190837175191 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00190837175191]

Moist Heat or Steam Sterilization

[00190837175191]

Moist Heat or Steam Sterilization

[00190837175191]

Moist Heat or Steam Sterilization

[00190837175191]

Moist Heat or Steam Sterilization

[00190837175191]

Moist Heat or Steam Sterilization

[00190837175191]

Moist Heat or Steam Sterilization

[00190837175191]

Moist Heat or Steam Sterilization

[00190837175191]

Moist Heat or Steam Sterilization

[00190837175191]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-12
• Device Publish Date: 2024-12-04

On-Brand Devices [ARx SAI]

• 00190837175382: 18-9570-09
• 00190837175238: 18-85100-09
• 00190837175191: 18-8580-09
• 00190837175177: 18-8570-09
• 00190837175214: 18-8590-09