EVOS Lumbar Interbody System 4284-014

GUDID 00841193111377

HA PEEK EVOS Rotate, , 14mmx11mmx 26mm , BICONVEX 0 degree

Quality Tech Services, Inc.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00841193111377
• NIH Device Record Key: 580ec44e-d69a-419f-97fc-3337348064f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOS Lumbar Interbody System
• Version Model Number: 4284-014
• Catalog Number: 4284-014
• Company DUNS: 075062344
• Company Name: Quality Tech Services, 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: 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

Customer Support Contacts

• Phone: +1(704)243-0892
• Email: B.Roof@cuttingedgespine.com

Device Dimensions

• Length: 26 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841193111377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150321

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-27

On-Brand Devices [EVOS Lumbar Interbody System]

• 00841193111377: HA PEEK EVOS Rotate, , 14mmx11mmx 26mm , BICONVEX 0 degree
• 00841193100296: EVOS Straight HA PEEK 13mm x 9mm x 26mm Biconvex 0°, Standard