P-LIFT®

GUDID 00190361003199

P-LIFT, Straight, Blunt, 8W X 27L X 13H

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190361003199
• NIH Device Record Key: e839a9c8-0a70-4a66-8b11-9a0ddf3c0135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P-LIFT®
• Version Model Number: 01-06021-13
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, 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

Customer Support Contacts

• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com

Device Dimensions

• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361003199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111553

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190361003199]

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: 2016-04-15

On-Brand Devices [P-LIFT®]

• 00190361037415: P-LIFT Gen II Inserter Assembly
• 00190361003274: Dorado P-LIFT IBC 8-10X30 Straight 14mm
• 00190361003267: Dorado P-LIFT IBC 8-10X30 Straight 13mm
• 00190361003250: Dorado P-LIFT IBC 8-10X30 Straight 12mm
• 00190361003243: Dorado P-LIFT IBC 8-10X30 Straight 11mm
• 00190361003236: Dorado P-LIFT IBC 8-10X30 Straight 10mm
• 00190361003229: Dorado P-LIFT IBC 8-10X30 Straight 9mm
• 00190361003212: Dorado P-LIFT IBC 8-10X30 Straight 8mm
• 00190361003205: P-LIFT, Straight, Blunt, 8W X 27L X 14H
• 00190361003199: P-LIFT, Straight, Blunt, 8W X 27L X 13H
• 00190361003182: P-LIFT, Straight, Blunt, 8W X 27L X 12H
• 00190361003175: P-LIFT, Straight, Blunt, 8W X 27L X 11H
• 00190361003168: P-LIFT, Straight, Blunt, 8W X 27L X 10H
• 00190361003151: P-LIFT, Straight, Blunt, 8W X 27L X 9H
• 00190361003144: P-LIFT, Straight, Blunt, 8W X 27L X 8H
• 00190361003137: P-LIFT, Lordotic, 9W X 24L X 14H
• 00190361003120: P-LIFT, Lordotic, 9W X 24L X 13H
• 00190361003113: P-LIFT, Lordotic, 9W X 24L X 12H
• 00190361003106: P-LIFT, Lordotic, 9W X 24L X 11H
• 00190361003090: P-LIFT, Lordotic, 9W X 24L X 10H
• 00190361003083: P-LIFT, Lordotic, 9W X 24L X 9H
• 00190361003076: Dorado Plift , Lordotic, 9Wx24L, 8L
• 00190361003069: P-LIFT, Straight, CONED, 8W X 27L X 14H
• 00190361003052: P-LIFT, Straight, CONED, 8W X 27L X 13H
• 00190361003045: P-LIFT, Straight, CONED, 8W X 27L X 12H
• 00190361003038: P-LIFT, Straight, CONED, 8W X 27L X 11H
• 00190361003021: P-LIFT, Straight, CONED, 8W X 27L X 10H
• 00190361003014: P-LIFT, Straight, CONED, 8W X 27L X 9H
• 00190361003007: P-LIFT, Straight, CONED, 8W X 27L X 8H
• 00190361002994: P-LIFT, CONED, 8W X 24L X 14H
• 00190361002987: P-LIFT, CONED, 8W X 24L X 13H
• 00190361002970: P-LIFT, CONED, 8W X 24L X 12H
• 00190361002963: P-LIFT, CONED, 8W X 24L X 11H
• 00190361002956: P-LIFT, CONED, 8W X 24L X 10H
• 00190361002949: P-LIFT, CONED, 8W X 24L X 9H
• 00190361002932: P-LIFT, CONED, 8W X 24L X 8H
• 00190361002925: Dorado P_LIF IBC, 8 X 14