10mm x 28mm x 12mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted

GUDID 00190837018665

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837018665
• NIH Device Record Key: 7674b464-e3ff-4b8d-b69f-0669ede6523a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10mm x 28mm x 12mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted
• Version Model Number: 52-1028-12T
• 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	00190837018665 [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

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

Moist Heat or Steam Sterilization

[00190837018665]

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

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