EVOL®ha-C Cervical Interbody System CES-389

GUDID 00841193121178

EVOL®ha-C Cervical TRIAL 18WX16D 7° 7H-8H

Cutting Edge Spine, LLC

Orthopaedic cement restrictor sizer

• Primary Device ID: 00841193121178
• NIH Device Record Key: 40d0acb0-4e7d-4cee-8023-ad57d72f59c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOL®ha-C Cervical Interbody System
• Version Model Number: CES-389
• Catalog Number: CES-389
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 400 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	00841193121178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180674

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00841193121178]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [EVOL®ha-C Cervical Interbody System]

• 00841193120843: Inserter Threaded Shaft
• 00841193120836: Cervical Inserter With Stop
• 00841193120829: Cervical Inserter
• 00841193121925: EVOL® HA Cervical Cage 18x16x10x7 deg
• 00841193121918: EVOL® HA Cervical Cage 18x16x09x7 deg
• 00841193121901: EVOL® HA Cervical Cage 18x16x08x7 deg
• 00841193121895: EVOL® HA Cervical Cage 18x16x07x7 deg
• 00841193121888: EVOL® HA Cervical Cage 16x14x10x7 deg
• 00841193121871: EVOL® HA Cervical Cage 16x14x09x7 deg
• 00841193121864: EVOL® HA Cervical Cage 16x14x08x7 deg
• 00841193121857: EVOL® HA Cervical Cage 16x14x07x7 deg
• 00841193121840: EVOL® HA Cervical Cage 16x14x06x7 deg
• 00841193121833: EVOL® HA Cervical Cage 16x14x05x7 deg
• 00841193121826: EVOL® HA Cervical Cage 16x12x10x7 deg
• 00841193121819: EVOL® HA Cervical Cage 16x12x09x7 deg
• 00841193121802: EVOL® HA Cervical Cage 16x12x08x7 deg
• 00841193121796: EVOL® HA Cervical Cage 16x12x07x7 deg
• 00841193121789: EVOL® HA Cervical Cage 16x12x06x7 deg
• 00841193121772: EVOL® HA Cervical Cage 16x12x05x7 deg
• 00841193121765: EVOL® HA Cervical Cage 14x14x10x7 deg
• 00841193121758: EVOL® HA Cervical Cage 14x14x09x7 deg
• 00841193121741: EVOL® HA Cervical Cage 14x14x08x7 deg
• 00841193121734: EVOL® HA Cervical Cage 14x14x07x7 deg
• 00841193121727: EVOL® HA Cervical Cage 14x14x06x7 deg
• 00841193121710: EVOL® HA Cervical Cage 14x14x05x7 deg
• 00841193121703: EVOL® HA Cervical Cage 14x12x10x7 deg
• 00841193121697: EVOL® HA Cervical Cage 14x12x09x7 deg
• 00841193121680: EVOL® HA Cervical Cage 14x12x08x7 deg
• 00841193121673: EVOL® HA Cervical Cage 14x12x07x7 deg
• 00841193121666: EVOL® HA Cervical Cage 14x12x06x7 deg
• 00841193121659: EVOL® HA Cervical Cage 14x12x05x7 deg
• 00841193121642: EVOL® HA Cervical Cage 12x12x10x7 deg
• 00841193121635: EVOL® HA Cervical Cage 12x12x09x7 deg
• 00841193121628: EVOL® HA Cervical Cage 12x12x08x7 deg
• 00841193121611: EVOL® HA Cervical Cage 12x12x07x7 deg
• 00841193121604: EVOL® HA Cervical Cage 12x12x06x7 deg
• 00841193121598: EVOL® HA Cervical Cage 12x12x05x7 deg
• 00841193121581: EVOL® HA Cervical Cage 18x16x10x4 deg
• 00841193121574: EVOL® HA Cervical Cage 18x16x09x4 deg
• 00841193121567: EVOL® HA Cervical Cage 18x16x08x4 deg
• 00841193121550: EVOL® HA Cervical Cage 18x16x07x4 deg
• 00841193121543: EVOL® HA Cervical Cage 16x14x10x4 deg
• 00841193121536: EVOL® HA Cervical Cage 16x14x09x4 deg
• 00841193121529: EVOL® HA Cervical Cage 16x14x08x4 deg
• 00841193121512: EVOL® HA Cervical Cage 16x14x07x4 deg
• 00841193121505: EVOL® HA Cervical Cage 16x14x06x4 deg
• 00841193121499: EVOL® HA Cervical Cage 16x14x05x4 deg
• 00841193121482: EVOL® HA Cervical Cage 16x12x10x4 deg
• 00841193121475: EVOL® HA Cervical Cage 16x12x09x4 deg
• 00841193121468: EVOL® HA Cervical Cage 16x12x08x4 deg