EVOL®ha-D Lateral Interbody Fusion System HA501810-10

GUDID 00841193123400

EVOL®ha LATERAL DLIF CAGE 10x18x50X10 deg

Cutting Edge Spine, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841193123400
• NIH Device Record Key: 8398aba3-fce9-412e-86fb-c2396c931971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOL®ha-D Lateral Interbody Fusion System
• Version Model Number: HA501810-10
• Catalog Number: HA501810-10
• Company DUNS: 069472647
• Company Name: Cutting Edge Spine, LLC
• 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: 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841193123400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192497

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00841193123400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-24
• Device Publish Date: 2020-02-14

On-Brand Devices [EVOL®ha-D Lateral Interbody Fusion System]

• 00841193124063: EVOL®ha LATERAL DLIF CAGE 14x22x60X15 deg
• 00841193124056: EVOL®ha LATERAL DLIF CAGE 12x22x60X15 deg
• 00841193124049: EVOL®ha LATERAL DLIF CAGE 10x22x60X15 deg
• 00841193124032: EVOL®ha LATERAL DLIF CAGE 14x22x55X15 deg
• 00841193124025: EVOL®ha LATERAL DLIF CAGE 12x22x55X15 deg
• 00841193124018: EVOL®ha LATERAL DLIF CAGE 10x22x55X15 deg
• 00841193124001: EVOL®ha LATERAL DLIF CAGE 14x22x50X15 deg
• 00841193123998: EVOL®ha LATERAL DLIF CAGE 12x22x50X15 deg
• 00841193123981: EVOL®ha LATERAL DLIF CAGE 10x22x50X15 deg
• 00841193123974: EVOL®ha LATERAL DLIF CAGE 14x22x45X15 deg
• 00841193123967: EVOL®ha LATERAL DLIF CAGE 12x22x45X15 deg
• 00841193123950: EVOL®ha LATERAL DLIF CAGE 10x22x45X15 deg
• 00841193123943: EVOL®ha LATERAL DLIF CAGE 14x22x60X10 deg
• 00841193123936: EVOL®ha LATERAL DLIF CAGE 12x22x60X10 deg
• 00841193123929: EVOL®ha LATERAL DLIF CAGE 10x22x60X10 deg
• 00841193123912: EVOL®ha LATERAL DLIF CAGE 8x22x60X10 deg
• 00841193123905: EVOL®ha LATERAL DLIF CAGE 14x22x55X10 deg
• 00841193123899: EVOL®ha LATERAL DLIF CAGE 12x22x55X10 deg
• 00841193123882: EVOL®ha LATERAL DLIF CAGE 10x22x55X10 deg
• 00841193123875: EVOL®ha LATERAL DLIF CAGE 8x22x55X10 deg
• 00841193123868: EVOL®ha LATERAL DLIF CAGE 14x22x50X10 deg
• 00841193123851: EVOL®ha LATERAL DLIF CAGE 12x22x50X10 deg
• 00841193123844: EVOL®ha LATERAL DLIF CAGE 10x22x50X10 deg
• 00841193123837: EVOL®ha LATERAL DLIF CAGE 8x22x50X10 deg
• 00841193123820: EVOL®ha LATERAL DLIF CAGE 14x22x45X10 deg
• 00841193123813: EVOL®ha LATERAL DLIF CAGE 12x22x45X10 deg
• 00841193123806: EVOL®ha LATERAL DLIF CAGE 10x22x45X10 deg
• 00841193123790: EVOL®ha LATERAL DLIF CAGE 8x22x45X10 deg
• 00841193123783: EVOL®ha LATERAL DLIF CAGE 14x22x60X00 deg
• 00841193123776: EVOL®ha LATERAL DLIF CAGE 12x22x60X00 deg
• 00841193123769: EVOL®ha LATERAL DLIF CAGE 10x22x60X00 deg
• 00841193123752: EVOL®ha LATERAL DLIF CAGE 8x22x60X00 deg
• 00841193123745: EVOL®ha LATERAL DLIF CAGE 14x22x55X00 deg
• 00841193123738: EVOL®ha LATERAL DLIF CAGE 12x22x55X00 deg
• 00841193123721: EVOL®ha LATERAL DLIF CAGE 10x22x55X00 deg
• 00841193123714: EVOL®ha LATERAL DLIF CAGE 8x22x55X00 deg
• 00841193123707: EVOL®ha LATERAL DLIF CAGE 14x22x50X00 deg
• 00841193123691: EVOL®ha LATERAL DLIF CAGE 12x22x50X00 deg
• 00841193123684: EVOL®ha LATERAL DLIF CAGE 10x22x50X00 deg
• 00841193123677: EVOL®ha LATERAL DLIF CAGE 8x22x50X00 deg
• 00841193123660: EVOL®ha LATERAL DLIF CAGE 14x22x45X00 deg
• 00841193123653: EVOL®ha LATERAL DLIF CAGE 12x22x45X00 deg
• 00841193123646: EVOL®ha LATERAL DLIF CAGE 10x22x45X00 deg
• 00841193123639: EVOL®ha LATERAL DLIF CAGE 8x22x45X00 deg
• 00841193123622: EVOL®ha LATERAL DLIF CAGE 14x18x60X15 deg
• 00841193123615: EVOL®ha LATERAL DLIF CAGE 12x18x60X15 deg
• 00841193123608: EVOL®ha LATERAL DLIF CAGE 10x18x60X15 deg
• 00841193123592: EVOL®ha LATERAL DLIF CAGE 14x18x55X15 deg
• 00841193123585: EVOL®ha LATERAL DLIF CAGE 12x18x55X15 deg
• 00841193123578: EVOL®ha LATERAL DLIF CAGE 10x18x55X15 deg