| Primary Device ID | 00195860008034 | 
| NIH Device Record Key | 193aead9-4cee-4f86-852a-d6de1cec3158 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | LLIF Interbody System | 
| Version Model Number | L-1308 | 
| Catalog Number | L-1308 | 
| Company DUNS | 116940934 | 
| Company Name | Evolution Spine LLC | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | 
| 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 | |
| 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 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Height | 8 Millimeter | 
| Width | 18 Millimeter | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00195860008034 [Primary] | 
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
[00195860008034]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-06-21 | 
| Device Publish Date | 2021-06-12 | 
| 00195860008171 | 22mm Lateral Trial 16mm Lordotic | 
| 00195860008164 | 22mm Lateral Trial 14mm Lordotic | 
| 00195860008157 | 22mm Lateral Trial 12mm Lordotic | 
| 00195860008140 | 22mm Lateral Trial 10mm Lordotic | 
| 00195860008133 | 22mm Lateral Trial 8mm Lordotic | 
| 00195860008126 | 22mm Lateral Trial 16mm Parallel | 
| 00195860008119 | 22mm Lateral Trial 14mm Parallel | 
| 00195860008102 | 22mm Lateral Trial 12mm Parallel | 
| 00195860008096 | 22mm Lateral Trial 10mm Parallel | 
| 00195860008089 | 22mm Lateral Trial 8mm Parallel | 
| 00195860008072 | 18mm Lateral Trial 16mm Lordotic | 
| 00195860008065 | 18mm Lateral Trial 14mm Lordotic | 
| 00195860008058 | 18mm Lateral Trial 12mm Lordotic | 
| 00195860008041 | 18mm Lateral Trial 10mm Lordotic | 
| 00195860008034 | 18mm Lateral Trial 8mm Lordotic | 
| 00195860008027 | 18mm Lateral Trial 16mm Parallel | 
| 00195860008010 | 18mm Lateral Trial 14mm Parallel | 
| 00195860008003 | 18mm Lateral Trial 12mm Parallel | 
| 00195860007990 | 18mm Lateral Trial 10mm Parallel | 
| 00195860007983 | 18mm Lateral Trial 8mm Parallel | 
| 00195860007976 | Lateral Slap Hammer | 
| 00195860007969 | Slap Hammer - Lateral Trial Adapter | 
| 00195860007952 | 18x55x16mm LLIF Cage 7 Deg Lordotic | 
| 00195860007945 | 18x55x14mm LLIF Cage 7 Deg Lordotic | 
| 00195860007938 | 18x55x12mm LLIF Cage 7 Deg Lordotic | 
| 00195860007921 | 18x55x10mm LLIF Cage 7 Deg Lordotic | 
| 00195860007914 | 18x50x16mm LLIF Cage 7 Deg Lordotic | 
| 00195860007907 | 18x50x14mm LLIF Cage 7 Deg Lordotic | 
| 00195860007891 | 18x50x12mm LLIF Cage 7 Deg Lordotic | 
| 00195860007884 | 18x50x10mm LLIF Cage 7 Deg Lordotic | 
| 00195860007877 | 18x45x16mm LLIF Cage 7 Deg Lordotic | 
| 00195860007860 | 18x45x14mm LLIF Cage 7 Deg Lordotic | 
| 00195860007853 | 18x45x12mm LLIF Cage 7 Deg Lordotic | 
| 00195860007846 | 18x45x10mm LLIF Cage 7 Deg Lordotic | 
| 00195860007839 | 18x40x16mm LLIF Cage 7 Deg Lordotic | 
| 00195860007822 | 18x40x14mm LLIF Cage 7 Deg Lordotic | 
| 00195860007815 | 18x40x12mm LLIF Cage 7 Deg Lordotic | 
| 00195860007808 | 18x40x10mm LLIF Cage 7 Deg Lordotic | 
| 00195860007792 | 18x35x16mm LLIF Cage 7 Deg Lordotic | 
| 00195860007785 | 18x35x14mm LLIF Cage 7 Deg Lordotic | 
| 00195860007778 | 18x35x12mm LLIF Cage 7 Deg Lordotic | 
| 00195860007761 | 18x35x10mm LLIF Cage 7 Deg Lordotic | 
| 00195860007754 | 18x30x16mm LLIF Cage 7 Deg Lordotic | 
| 00195860007747 | 18x30x14mm LLIF Cage 7 Deg Lordotic | 
| 00195860007730 | 18x30x12mm LLIF Cage 7 Deg Lordotic | 
| 00195860007723 | 18x30x10mm LLIF Cage 7 Deg Lordotic | 
| 00195860007716 | 18x55x16mm LLIF Cage Parallel | 
| 00195860007709 | 18x55x14mm LLIF Cage Parallel | 
| 00195860007693 | 18x55x12mm LLIF Cage Parallel | 
| 00195860007686 | 18x55x10mm LLIF Cage Parallel |