| Primary Device ID | 00195860005835 |
| NIH Device Record Key | 838ba684-680d-4f3e-9b44-969a3f3a8885 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cervical Interbody Fusion System |
| Version Model Number | CLP1014 |
| Catalog Number | CLP1014 |
| 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 |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Depth | 16 Millimeter |
| Width | 14 Millimeter |
| Height | 14 Millimeter |
| Angle | 10 degree |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195860005835 [Primary] |
| ODP | Intervertebral fusion device with bone graft, cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
[00195860005835]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-02 |
| Device Publish Date | 2021-05-25 |
| 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 |