Plateau 2018-0017

GUDID 00190837032289

T30 Locking Cap Removal Driver

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837032289
• NIH Device Record Key: be820d0d-804b-476a-9105-980ea120fa34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau
• Version Model Number: 2018-0017
• Catalog Number: 2018-0017
• 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	00190837032289 [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

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

Moist Heat or Steam Sterilization

[00190837032289]

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

Devices Manufactured by Life Spine, Inc.

• 00190837205034 - ARx: 2025-01-16
• 00190837205041 - ARx: 2025-01-16
• 00190837175405 - ARx SAI: 2025-01-13
• 00190837175429 - ARx SAI: 2025-01-13
• 00190837175443 - ARx SAI: 2025-01-13
• 00190837175610 - ARx SAI: 2025-01-13
• 00190837175634 - ARx SAI: 2025-01-13
• 00190837175214 - ARx SAI: 2024-12-16