E3D-A Anchor System 112-A011

GUDID 00195860023266

E3D-A Anchor Inserter 11 mm

Evolution Spine LLC

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00195860023266
• NIH Device Record Key: 9cbde64d-2e0c-4b52-9bfb-74e767d7df3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E3D-A Anchor System
• Version Model Number: 112-A011
• Catalog Number: 112-A011
• Company DUNS: 116940934
• Company Name: Evolution Spine LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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	00195860023266 [Primary]

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

[00195860023266]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-03
• Device Publish Date: 2024-05-24

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• 00195860023297: E3D-A Anchor Inserter 15 mm
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• 00195860023273: E3D-A Anchor Inserter 12 mm
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• 00195860023259: Angled Anchor Extractor
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• 00195860023235: Anchor Inserter Drawbar
• 00195860023228: Anchor Inserter Tamp
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• 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
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• 40195860023196: HAnano E3D-A Anchors 25mm PACK OF 3
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