Plateau-Z 10mm x 24mm x 16mm, 0°

GUDID 00190837017866

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837017866
• NIH Device Record Key: 5df414e3-db37-433f-be20-e755d5c62a56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau-Z 10mm x 24mm x 16mm, 0°
• Version Model Number: 43-1024-16
• 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	00190837017866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111569

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837017866]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-12-20

Devices Manufactured by Life Spine, Inc.

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• 00190837171537 - ARx MIS: 2025-03-07
• 00190837205034 - ARx: 2025-01-16
• 00190837205041 - ARx: 2025-01-16
• 00190837175405 - ARx SAI: 2025-01-13