Avatar Spinal System 114-082

GUDID 00819454010813

Pedicle Screw System

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00819454010813
• NIH Device Record Key: 2e6d0e1d-66c4-4c65-97d3-6d96957d4306
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avatar Spinal System
• Version Model Number: 114-082
• Catalog Number: 114-082
• 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: false
• 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	00819454010813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111953

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

[00819454010813]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-11-19

On-Brand Devices [Avatar Spinal System]

• 00819454010813: Pedicle Screw System
• 00190837101749: Beveled-Tip Jamshidi