E3D-A Anchor System 112G-20

GUDID 10195860023188

E3D-A Anchors 20mm

Evolution Spine LLC

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• Primary Device ID: 10195860023188
• NIH Device Record Key: a96323a4-6a07-4c40-954c-f491310f7c2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E3D-A Anchor System
• Version Model Number: 112G-20
• Catalog Number: 112G-20
• 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: true
• 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
• 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 Dimensions

• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10195860023188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240368

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-06
• Device Publish Date: 2024-05-29

On-Brand Devices [E3D-A Anchor System]

• 40195860023202: HAnano E3D-A Anchors 30mm PACK OF 3
• 40195860023189: HAnano E3D-A Anchors 20mm PACK OF 3
• 30195860023205: HAnano E3D-A Anchors 30mm PACK OF 2
• 30195860023182: HAnano E3D-A Anchors 20mm PACK OF 2
• 20195860023208: HAnano E3D-A Anchors 30mm
• 00195860023471: Freehand Anchor Tamp
• 00195860023389: ALIF Anchor Upper Tray
• 00195860023334: ALIF Anchor Caddy
• 00195860023327: ALIF Anchor Tray
• 00195860023310: E3D-A Anchor Inserter 19 mm
• 00195860023303: E3D-A Anchor Inserter 17 mm
• 00195860023297: E3D-A Anchor Inserter 15 mm
• 00195860023280: E3D-A Anchor Inserter 13 mm
• 00195860023273: E3D-A Anchor Inserter 12 mm
• 00195860023266: E3D-A Anchor Inserter 11 mm
• 00195860023259: Angled Anchor Extractor
• 00195860023242: Straight Anchor Extractor
• 00195860023235: Anchor Inserter Drawbar
• 00195860023228: Anchor Inserter Tamp
• 00195860023211: Anchor Mallet
• 00195860023198: E3D-A Anchor (Non-Sterile) 25mm
• 20195860023192: HAnano E3D-A Anchors 25mm
• 20195860023185: HAnano E3D-A Anchors 20mm
• 10195860023201: E3D-A Anchors 30mm
• 10195860023195: E3D-A Anchors 25mm
• 10195860023188: E3D-A Anchors 20mm
• 00195860023204: E3D-A Anchor (Non-Sterile) 30mm
• 00195860023181: E3D-A Anchor (Non-Sterile) 20mm
• 40195860023196: HAnano E3D-A Anchors 25mm PACK OF 3
• 30195860023199: HAnano E3D-A Anchors 25mm PACK OF 2