ProLift Wedge

GUDID 00190837107703

Life Spine, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190837107703
• NIH Device Record Key: bce5e8ca-d7e2-4f16-ae36-bb580698ab13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProLift Wedge
• Version Model Number: 70-1028-1115
• 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	00190837107703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203361

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

[00190837107703]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [ProLift Wedge]

• 00190837107741: 70-1028-0815
• 00190837107697: 70-1028-1015
• 00190837107758: 70-1028-0915
• 00190837152369: 70-1228-1615
• 00190837152352: 70-1228-1415
• 00190837152345: 70-1228-1215
• 00190837152338: 70-1228-1115
• 00190837152321: 70-1228-1015
• 00190837152314: 70-1228-0915
• 00190837152307: 70-1228-0815
• 00190837107734: 70-1028-1615
• 00190837107727: 70-1028-1415
• 00190837107710: 70-1028-1215
• 00190837107703: 70-1028-1115
• 00190837143046: 180-103
• 00190837140779: 180-102
• 00190837145651: 70-1028-1315
• 00190837152840: L180-103
• 00190837145668: 70-1028-1515
• 00190837154868: 114-280-5
• 00190837152703: L129-521
• 00190837152697: L129-520
• 00190837152680: L129-519
• 00190837152673: L129-518
• 00190837152666: L129-517
• 00190837152659: L129-516
• 00190837152642: L129-515
• 00190837152635: L129-514
• 00190837152628: L129-513
• 00190837152611: L129-512
• 00190837152604: L129-511
• 00190837152598: L114-280-5
• 00190837152581: L114-280-4
• 00190837152574: L114-280-2
• 00190837152567: L114-280-1
• 00190837145644: 114-280-4
• 00190837145620: 114-280-2
• 00190837145613: 114-280-1
• 00190837200060: L180-104
• 00190837156077: 180-104