10mm x 24mm x 13mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted

GUDID 00190837018924

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837018924
• NIH Device Record Key: 92d8cc74-0766-4566-8954-35466cf00d86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10mm x 24mm x 13mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted
• Version Model Number: 54-1024-713T
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: true
• 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	00190837018924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130630

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837018924]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-20

Devices Manufactured by Life Spine, Inc.

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• 00190837138974 - ProLift: 2024-02-08
• 00190837169411 - TruLift: 2024-02-02
• 00190837116248 - Aileron: 2023-11-16
• 00190837168322 - ARx: 2023-11-16
• 00190837135393 - ARx: 2023-10-16