ProLift Pivot-U

GUDID 00190837204846

Life Spine, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190837204846
• NIH Device Record Key: 1a28af2e-703a-4627-a6dd-5bc1216968ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProLift Pivot-U
• Version Model Number: 15-1036-1508
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00190837204846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243668

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-27
• Device Publish Date: 2026-01-19

On-Brand Devices [ProLift Pivot-U]

• 00190837204853: 15-1036-1510
• 00190837204846: 15-1036-1508
• 00190837204839: 15-1036-1210
• 00190837204822: 15-1036-1208
• 00190837204815: 15-1036-1015
• 00190837204808: 15-1036-0813
• 00190837204792: 15-1036-0710
• 00190837204785: 15-1036-0708
• 00190837204778: 15-1034-1510
• 00190837204761: 15-1034-1508
• 00190837204754: 15-1034-1210
• 00190837204747: 15-1034-1208
• 00190837204730: 15-1034-1015
• 00190837204716: 15-1034-0710
• 00190837204709: 15-1034-0708
• 00190837203047: 15-1032-1015
• 00190837202965: 15-1030-1015
• 00190837202880: 15-1028-1015
• 00190837202804: 15-1026-1015