Neo 113-947

GUDID 00190837035334

OCT Plate Bender

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837035334
• NIH Device Record Key: 572e777b-88f6-42fc-b14c-12e9f28f053c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo
• Version Model Number: 113-947
• Catalog Number: 113-947
• 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	00190837035334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040844

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

[00190837035334]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Neo]

• 00190837035334: OCT Plate Bender
• 00190837035327: Neo Remover Driver
• 00190837035310: NEO 4-5 Level ACP Block
• 00190837035303: NEO 1-3 Level ACP Block
• 00190837035297: NEO 50mm Three Level Anterior Cervical Plate