Plateau-A 126-267

GUDID 00190837034627

Plateau-A Trial 34 x 28 x 11, 12°

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837034627
• NIH Device Record Key: b6c4ee71-b2bf-46d1-b8b4-e7ac3624a9af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau-A
• Version Model Number: 126-267
• Catalog Number: 126-267
• 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	00190837034627 [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

[00190837034627]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-07

On-Brand Devices [Plateau-A]

• 00190837034627: Plateau-A Trial 34 x 28 x 11, 12°
• 00190837034610: Plateau-A Trial, 30 x 24 x 11, 12°