Emerge Cervical Plate

GUDID 00195860031797

Emerge Cervical Implant Tray V2 Bottom Level

Evolution Spine LLC

Instrument tray, reusable

• Primary Device ID: 00195860031797
• NIH Device Record Key: 03a00688-2554-4568-85bd-456819e406d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emerge Cervical Plate
• Version Model Number: 100-A088
• Company DUNS: 116940934
• Company Name: Evolution 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: false
• Manufacturing Date: false
• 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(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com
• Phone: +1(214)281-8871
• Email: info@evolutionspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860031797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212405

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

[00195860031797]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-28
• Device Publish Date: 2026-01-20

On-Brand Devices [Emerge Cervical Plate]

• 00195860031797: Emerge Cervical Implant Tray V2 Bottom Level
• 00195860031780: Emerge Anterior Cervical Plate System Caddy V2 Fixed Cervical Screws
• 00195860031773: Emerge Anterior Cervical Plate System Caddy V2 Variable Cervical Screws
• 00195860031766: Emerge Anterior Cervical Plate System Caddy V2 5 Level Plates
• 00195860031759: Emerge Anterior Cervical Plate System Caddy V2 4 Level Plates
• 00195860031742: Emerge Anterior Cervical Plate System Caddy V2 3 Level Plates
• 00195860031735: Emerge Anterior Cervical Plate System Caddy V2 1 & 2 Level Plates
• 00195860031728: Emerge Cervical Instrument Tray V2 Top Level