EVOL® Lumbar Interbody System HLB04012

GUDID 00841193120751

10X12mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage

Cutting Edge Spine, LLC

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00841193120751
• NIH Device Record Key: 2059ae07-9fec-486b-9c66-561d7ad25ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOL® Lumbar Interbody System
• Version Model Number: HLB04012
• Catalog Number: HLB04012
• Company DUNS: 069472647
• Company Name: Cutting Edge Spine, LLC
• 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: true
• 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: 23 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	00841193120751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180891

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00841193120751]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-08-15

On-Brand Devices [EVOL® Lumbar Interbody System]

• 00841193120805: 15X17mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage
• 00841193120799: 14X16mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage
• 00841193120782: 13X15mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage
• 00841193120775: 12X14mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage
• 00841193120768: 11X13mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage
• 00841193120751: 10X12mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage
• 00841193120744: 7X9mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage
• 00841193120737: 8X10mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage
• 00841193120720: 9X11mm,X 10mm X 23 mm HA PEEK, Lordotic LIF Cage