Cervical Interbody Fusion System CLP1013

GUDID 00195860005828

Cervical IBD, 14x16x13mm, 10 Deg

Evolution Spine LLC

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• Primary Device ID: 00195860005828
• NIH Device Record Key: 9c191b34-7b21-452e-958b-2c4682ede3a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervical Interbody Fusion System
• Version Model Number: CLP1013
• Catalog Number: CLP1013
• 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

• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree
• Height: 13 Millimeter
• Depth: 16 Millimeter
• Width: 14 Millimeter
• Angle: 10 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860005828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160324

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

[00195860005828]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-02
• Device Publish Date: 2021-05-25

On-Brand Devices [Cervical Interbody Fusion System]

• 00195860012703: 14x16x 10mm, 11mm , 10 Deg Trial - No Stop
• 00195860012697: 14x16x 8mm, 9mm , 10 Deg Trial - No Stop
• 00195860012680: 14x16x 6mm, 7mm, 10 Deg Trial - No Stop
• 00195860012673: 14x16x 10mm, 11mm , 6 Deg Trial - No Stop
• 00195860012666: 14x16x 8mm, 9mm , 6 Deg Trial - No Stop
• 00195860012659: 14x16x 6mm, 7mm, 6 Deg Trial - No Stop
• 00195860012642: 14x16x 5mm, 6 Deg Trial - No Stop
• 00195860012635: 12x14x 10mm, 11mm , 10 Deg Trial - No Stop
• 00195860012628: 12x14x 8mm, 9mm , 10 Deg Trial - No Stop
• 00195860012611: 12x14x 6mm, 7mm, 10 Deg Trial - No Stop
• 00195860012604: 12x14x 10mm, 11mm , 6 Deg Trial - No Stop
• 00195860012598: 12x14x 8mm, 9mm , 6 Deg Trial - No Stop
• 00195860012581: 12x14x 6mm, 7mm, 6 Deg Trial - No Stop
• 00195860012574: 12x14x 5mm, 6 Deg Trial - No Stop
• 00195860006139: ACDF Implants Caddy Lid
• 00195860006122: ACDF Large Implants Caddy
• 00195860006115: ACDF Small Implants Caddy
• 00195860006108: ACDF Large Implants / Instruments Tray
• 00195860006092: ACDF Small Implants / Instruments Tray
• 00195860006085: ACDF Tray Lid
• 00195860006078: 14x16x 10mm, 11mm , 10 Deg Trial
• 00195860006061: 14x16x 8mm, 9mm , 10 Deg Trial
• 00195860006054: 14x16x 6mm, 7mm, 10 Deg Trial
• 00195860006047: 14x16x 10mm, 11mm , 6 Deg Trial
• 00195860006030: 14x16x 8mm, 9mm , 6 Deg Trial
• 00195860006023: 14x16x 6mm, 7mm, 6 Deg Trial
• 00195860006016: 14x16x 5mm, 6 Deg, 10 Deg Trial
• 00195860006009: 12x14x 10mm, 11mm , 10 Deg Trial
• 00195860005996: 12x14x 8mm, 9mm , 10 Deg Trial
• 00195860005989: 12x14x 6mm, 7mm, 10 Deg Trial
• 00195860005972: 12x14x 10mm, 11mm , 6 Deg Trial
• 00195860005965: 12x14x 8mm, 9mm , 6 Deg Trial
• 00195860005958: 12x14x 6mm, 7mm, 6 Deg Trial
• 00195860005941: 12x14x5mm, 6 Deg, 10 Deg Trial
• 00195860005934: 14x16x 10mm, 11mm Rasp
• 00195860005927: 14x16x 8mm, 9mm Rasp
• 00195860005910: 14x16x 6mm, 7mm Rasp
• 00195860005903: 14x16x5mm Rasp
• 00195860005897: 12x14x 10mm, 11mm Rasp
• 00195860005880: 12x14x 8mm, 9mm Rasp
• 00195860005873: 12x14x 6mm, 7mm Rasp
• 00195860005866: 12x14x5mm Rasp
• 00195860005859: Cervical Tamp
• 00195860005842: Cervical Inserter
• 00195860005835: Cervical IBD, 14x16x14mm, 10 Deg
• 00195860005828: Cervical IBD, 14x16x13mm, 10 Deg
• 00195860005811: Cervical IBD, 14x16x12mm, 10 Deg
• 00195860005804: Cervical IBD, 14x16x11mm, 10 Deg
• 00195860005798: Cervical IBD, 14x16x10mm, 10 Deg
• 00195860005781: Cervical IBD, 14x16x9mm, 10 Deg