Plateau-C Instruments 2019-0031

GUDID 00190837032401

14mm X 11mm Rasp/Trial, 7°, 11mm, Short Stop

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837032401
• NIH Device Record Key: 8a101f8a-13af-4e8b-bf59-22a2555c5303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau-C Instruments
• Version Model Number: 2019-0031
• Catalog Number: 2019-0031
• 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: false
• 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	00190837032401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111835

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00190837032401]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-07

On-Brand Devices [Plateau-C Instruments]

• 00190837032494: Wedge Installer
• 00190837032487: Disc Cutter
• 00190837032470: DECORTICATION TUBE
• 00190837032463: Guide Tube
• 00190837032456: Rasp
• 00190837032449: Access Chisel
• 00190837032432: 14mm X 11mm Rasp/Trial, 7°, 14mm, Short Stop
• 00190837032425: 14mm X 11mm Rasp/Trial, 7°, 13mm, Short Stop
• 00190837032418: 14mm X 11mm Rasp/Trial, 7°, 12mm, Short Stop
• 00190837032401: 14mm X 11mm Rasp/Trial, 7°, 11mm, Short Stop
• 00190837032395: 14mm X 11mm Rasp/Trial, 7°, 10mm, Short Stop
• 00190837032388: 14mm X 11mm Rasp/Trial, 7°, 9mm, Short Stop
• 00190837032371: 14mm X 11mm Rasp/Trial, 7°, 8mm, Short Stop
• 00190837032364: 14mm X 11mm Rasp/Trial, 7°, 7mm, Short Stop
• 00190837032357: 14mm X 11mm Rasp/Trial, 7°, 6mm, Short Stop
• 00190837032340: 14mm X 11mm Rasp/Trial, 7°, 5mm, Short Stop