Lumbar IBFD KTC2-281016

GUDID B084KTC22810160

KEOS

Polymeric spinal interbody fusion cage

• Primary Device ID: B084KTC22810160
• NIH Device Record Key: ede07dd9-c555-4c9b-b150-196f1a6c11c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar IBFD
• Version Model Number: 28L x 10W x 16H Curved, HA
• Catalog Number: KTC2-281016
• Company DUNS: 080551837
• Company Name: KEOS
• 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: true
• 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
HIBCC	B084KTC22810160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160631

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B084KTC22810160]

Moist Heat or Steam Sterilization

[B084KTC22810160]

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: 2018-02-22

On-Brand Devices [Lumbar IBFD]

• B084KTS22810160: 28L x 10W x 16H Straight, HA
• B084KTS22810150: 28L x 10W x 15H Straight, HA
• B084KTS22810140: 28L x 10W x 14H Straight, HA
• B084KTS22810130: 28L x 10W x 13H Straight, HA
• B084KTS22810120: 28L x 10W x 12H Straight, HA
• B084KTS22810110: 28L x 10W x 11H Straight, HA
• B084KTS22810100: 28L x 10W x 10H Straight, HA
• B084KTS22810090: 28L x 10W x 9H Straight, HA
• B084KTS22810080: 28L x 10W x 8H Straight, HA
• B084KTS22810070: 28L x 10W x 7H Straight, HA
• B084KTS22810060: 28L x 10W x 6H Straight, HA
• B084KTS12810160: 28L x 10W x 16H Straight
• B084KTS12810150: 28L x 10W x 15H Straight
• B084KTS12810140: 28L x 10W x 14H Straight
• B084KTS12810130: 28L x 10W x 13H Straight
• B084KTS12810120: 28L x 10W x 12H Straight
• B084KTS12810110: 28L x 10W x 11H Straight
• B084KTS12810100: 28L x 10W x 10H Straight
• B084KTS12810090: 28L x 10W x 9H Straight
• B084KTS12810080: 28L x 10W x 8H Straight
• B084KTS12810070: 28L x 10W x 7H Straight
• B084KTS12810060: 28L x 10W x 6H Straight
• B084KTC22810160: 28L x 10W x 16H Curved, HA
• B084KTC22810150: 28L x 10W x 15H Curved, HA
• B084KTC22810140: 28L x 10W x 14H Curved, HA
• B084KTC22810130: 28L x 10W x 13H Curved, HA
• B084KTC22810120: 28L x 10W x 12H Curved, HA
• B084KTC22810110: 28L x 10W x 11H Curved, HA
• B084KTC22810100: 28L x 10W x 10H Curved, HA
• B084KTC22810090: 28L x 10W x 9H Curved, HA
• B084KTC22810080: 28L x 10W x 8H Curved, HA
• B084KTC22810070: 28L x 10W x 7H Curved, HA
• B084KTC22810060: 28L x 10W x 6H Curved, HA
• B084KTC12810160: 28L x 10W x 16H Curved
• B084KTC12810150: 28L x 10W x 15H Curved
• B084KTC12810140: 28L x 10W x 14H Curved
• B084KTC12810130: 28L x 10W x 13H Curved
• B084KTC12810120: 28L x 10W x 12H Curved
• B084KTC12810110: 28L x 10W x 11H Curved
• B084KTC12810100: 28L x 10W x 10H Curved
• B084KTC12810090: 28L x 10W x 9H Curved
• B084KTC12810080: 28L x 10W x 8H Curved
• B084KTC12810070: 28L x 10W x 7H Curved
• B084KTC12810060: 28L x 10W x 6H Curved
• B084KPS22310160: 23L x 10W x 16H Straight, HA
• B084KPS22310150: 23L x 10W x 15H Straight, HA
• B084KPS22310140: 23L x 10W x 14H Straight, HA
• B084KPS22310130: 23L x 10W x 13H Straight, HA
• B084KPS22310120: 23L x 10W x 12H Straight, HA
• B084KPS22310110: 23L x 10W x 11H Straight, HA