K121116

GUDID 00190837016029

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837016029
• NIH Device Record Key: 0b7866e8-262c-48a9-9404-0dac2700bda4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K121116
• Version Model Number: 89-1860-708
• 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	00190837016029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121116

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837016029]

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: 2016-12-19

Devices Manufactured by Life Spine, Inc.

• 00190837200312 - ProLift: 2025-09-22
• 00190837200329 - ProLift: 2025-09-22
• 00190837155001 - Lateral Disc Prep: 2025-09-19
• 00190837155353 - ProLift Lateral: 2025-09-19
• 00190837202774 - ProLift Pivot: 2025-08-29
• 00190837171889 - AVATAR Minimally Invasive Spinal System Instruments: 2025-07-15
• 00190837142186 - ProLift: 2025-07-09
• 00190837037499 - ProLift Lateral: 2025-07-02