Plateau Ti Curved 114-100

GUDID 00190837061081

Empty Plateau Large Instrumentation Tray

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837061081
• NIH Device Record Key: 43256c67-e2de-46e6-982b-27a471ef6bff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau Ti Curved
• Version Model Number: 114-100
• Catalog Number: 114-100
• 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	00190837061081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130630

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

[00190837061081]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Plateau Ti Curved]

• 00190837018870: 55-1027-16T
• 00190837018863: 55-1027-15T
• 00190837018856: 55-1027-14T
• 00190837018849: 55-1027-13T
• 00190837018832: 55-1027-12T
• 00190837018825: 55-1027-11T
• 00190837018818: 55-1027-10T
• 00190837018801: 55-1027-09T
• 00190837018795: 55-1027-08T
• 00190837061210: Angled Fishtail Tamp
• 00190837061203: Straight Tamp
• 00190837061197: Interfacing Impactor, Large
• 00190837061180: Modified Hudson T-Handle
• 00190837061173: Plateau Remover
• 00190837061166: Removable Sleeve, Plateau Installer
• 00190837061159: Plateau Installer
• 00190837061142: Modified Hudson Paddle Shaver, 15mm
• 00190837061135: Modified Hudson Paddle Shaver, 14mm
• 00190837061326: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 16mm, 0 De
• 00190837061319: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 15mm, 0 De
• 00190837061302: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 14mm, 0 De
• 00190837061296: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 13mm, 0 De
• 00190837061289: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 12mm, 0 De
• 00190837061272: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 11mm, 0 De
• 00190837061265: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 10mm, 0 De
• 00190837061258: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 9mm, 0 Deg
• 00190837061241: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 8mm, 0 Deg
• 00190837061234: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 7mm, 0 Deg
• 00190837061227: Plateau, Bulleted, Curved Spacer, Titanium 32mm x 6mm, 0 Deg
• 00190837061128: Plateau Ti 34mm Spacer System-Curved
• 00190837061111: Plateau Titanium 10x24 0 deg, Straight, Bulleted
• 00190837061104: Plateau Titanium Spacer System - Curved
• 00190837061098: Shaver/Trial Insert
• 00190837061081: Empty Plateau Large Instrumentation Tray
• 00190837061074: Spacer Caddy