E3D-C Interbody System 130-A160

GUDID 00195860032114

TRIAL 20 X 16mm 15DEG 11mm-12mm

Evolution Spine LLC

Spinal implant trial

• Primary Device ID: 00195860032114
• NIH Device Record Key: 05fb2a47-75fc-46e4-b42c-3fbb358c3a74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E3D-C Interbody System
• Version Model Number: 130-A160
• Catalog Number: 130-A160
• 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)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860032114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241846

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-02
• Device Publish Date: 2026-02-20

On-Brand Devices [E3D-C Interbody System]

• 10195860031718: Static Cervical 22x19mm 15Deg 12mm
• 10195860031701: Static Cervical 22x19mm 15Deg 11mm
• 10195860031695: Static Cervical 22x19mm 15Deg 10mm
• 10195860031688: Static Cervical 22x19mm 15Deg 9mm
• 10195860031671: Static Cervical 22x19mm 15Deg 8mm
• 10195860031664: Static Cervical 22x19mm 15Deg 7mm
• 10195860031657: Static Cervical 22x19mm 15Deg 6mm
• 10195860031640: Static Cervical 22x19mm 12Deg 12mm
• 10195860031633: Static Cervical 22x19mm 12Deg 11mm
• 10195860031626: Static Cervical 22x19mm 12Deg 10mm
• 10195860031619: Static Cervical 22x19mm 12Deg 9mm
• 10195860031602: Static Cervical 22x19mm 12Deg 8mm
• 10195860031596: Static Cervical 22x19mm 12Deg 7mm
• 10195860031589: Static Cervical 22x19mm 12Deg 6mm
• 10195860031572: Static Cervical 22x19mm 7Deg 12mm
• 10195860031565: Static Cervical 22x19mm 7Deg 11mm
• 10195860031558: Static Cervical 22x19mm 7Deg 10mm
• 10195860031541: Static Cervical 22x19mm 7Deg 9mm
• 10195860031534: Static Cervical 22x19mm 7Deg 8mm
• 10195860031527: Static Cervical 22x19mm 7Deg 7mm
• 10195860031510: Static Cervical 22x19mm 7Deg 6mm
• 10195860031503: Static Cervical 22x19mm 7Deg 5mm
• 10195860031497: Static Cervical 20x16mm 15Deg 12mm
• 10195860031480: Static Cervical 20x16mm 15Deg 11mm
• 10195860031473: Static Cervical 20x16mm 15Deg 10mm
• 10195860031466: Static Cervical 20x16mm 15Deg 9mm
• 10195860031459: Static Cervical 20x16mm 15Deg 8mm
• 10195860031442: Static Cervical 20x16mm 15Deg 7mm
• 10195860031435: Static Cervical 20x16mm 15Deg 6mm
• 10195860031428: Static Cervical 20x16mm 12Deg 12mm
• 10195860031411: Static Cervical 20x16mm 12Deg 11mm
• 10195860031404: Static Cervical 20x16mm 12Deg 10mm
• 10195860031398: Static Cervical 20x16mm 12Deg 9mm
• 10195860031381: Static Cervical 20x16mm 12Deg 8mm
• 10195860031374: Static Cervical 20x16mm 12Deg 7mm
• 10195860031367: Static Cervical 20x16mm 12Deg 6mm
• 10195860031350: Static Cervical 20x16mm 7Deg 12mm
• 10195860031343: Static Cervical 20x16mm 7Deg 11mm
• 10195860031336: Static Cervical 20x16mm 7Deg 10mm
• 10195860031329: Static Cervical 20x16mm 7Deg 9mm
• 10195860031312: Static Cervical 20x16mm 7Deg 8mm
• 10195860031305: Static Cervical 20x16mm 7Deg 7mm
• 10195860031299: Static Cervical 20x16mm 7Deg 6mm
• 10195860031282: Static Cervical 20x16mm 7Deg 5mm
• 10195860031275: Static Cervical 20x14mm 15Deg 12mm
• 10195860031268: Static Cervical 20x14mm 15Deg 11mm
• 10195860031251: Static Cervical 20x14mm 15Deg 10mm
• 10195860031244: Static Cervical 20x14mm 15Deg 9mm
• 10195860031237: Static Cervical 20x14mm 15Deg 8mm
• 10195860031220: Static Cervical 20x14mm 15Deg 7mm