| Primary Device ID | 00840606158213 | 
| NIH Device Record Key | cb09566a-6dbe-4590-b759-6ecde212dc39 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Karma | 
| Version Model Number | 75310-000 | 
| Company DUNS | 610712213 | 
| Company Name | SPINAL ELEMENTS, INC. | 
| 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 | true | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840606158213 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
[00840606158213]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-03-11 | 
| Device Publish Date | 2020-03-03 | 
| 08406061019500 | Karma Advancer | 
| 08406061019494 | Karma Retriever | 
| 00840606116183 | Karma Advancer | 
| 00840606116176 | Karma Retriever | 
| 00840606116169 | Tensioner with Cutoff | 
| 00840606116152 | KARMA® TENSIONER | 
| 00840606155946 | Karma® Implant Caddy Lid | 
| 00840606155977 | Flexible Rasp Caddy Lid | 
| 00840606155960 | Flexible Rasp Caddy Base | 
| 00840606155953 | Flexible Rasp Caddy | 
| 00840606155939 | Karma® Implant Caddy Base | 
| 00840606155922 | Karma® Implant Caddy | 
| 00840606155915 | Karma® Tray Bottom Level | 
| 00840606144841 | KARM TRAY TOP TIER | 
| 00840606144834 | KARMA TRAY LID | 
| 00840606144827 | KARMA TRAY BASE | 
| 00840606144810 | KARMA TRAY | 
| 00840606154901 | Head Pusher | 
| 00840606158237 | DRILL CARTRIDGE - .095 SHAFT | 
| 00840606158220 | DRILL CARTRIDGE - .071 SHAFT | 
| 00840606158213 | KARMA DRILL | 
| 00840606158206 | REMOVAL CUTTER | 
| 00840606158190 | STRAIGHT BALL TIP PROBE | 
| 00840606158183 | DIA. 4.5MM AWL | 
| 00840606158923 | CANNULATED KARMA RETRIEVER | 
| 00840606158916 | CANNULATED Ø4.5MM DRILL | 
| 00840606158909 | CANNULATED Ø4.5MM AWL | 
| 00840606158893 | CANNULATED 23MM SPAN DOCKING PROBE | 
| 00840606158886 | KARMA ACCESS TUBE - 100MM | 
| 00840606158879 | KARMA ACCESS TUBE - 90MM | 
| 00840606158862 | KARMA ACCESS TUBE - 80MM | 
| 00840606158855 | KARMA ACCESS TUBE - 70MM | 
| 00840606158848 | KARMA ACCESS TUBE - 60MM | 
| 00840606158831 | KARMA ACCESS TUBE - 50MM | 
| 00840606158824 | KARMA ACCESS TUBE - 40MM | 
| 00840606158817 | FINAL DILATOR | 
| 00840606158800 | SECOND DILATOR | 
| 00840606158794 | INITIAL DILATOR | 
| 00840606116145 | PEEK Cerclage | 
| 00840606116138 | PEEK Cerclage | 
| 00840606160803 | LAMINA BURR GUIDE | 
| 00840606149891 | 17MM SPAN DRILL GUIDE | 
| 00840606149884 | 17MM SPAN DOCKING PROBE | 
| 00840606149877 | 23MM SPAN DOCKING PROBE | 
| 00840606145022 | FLUSH CUTTER | 
| 00840606145015 | CURVED BALL TIP PROBE | 
| 00840606145008 | CURVED PROBE | 
| 00840606144995 | CARTRIDGE TOOL | 
| 00840606144988 | 23MM SPAN DRILL GUIDE | 
| 00840606144971 | Ø4.5mm DRILL | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  KARMA  98683283  not registered Live/Pending | REVEAL LASERS, LLC 2024-08-05 | 
|  KARMA  98171382  not registered Live/Pending | Univeral Yarn Inc. 2023-09-08 | 
|  KARMA  97894197  not registered Live/Pending | CervecerÃa Centro Americana, S.A. 2023-04-18 | 
|  KARMA  97852935  not registered Live/Pending | Silver Lake T-shirts LLC 2023-03-23 | 
|  KARMA  97827269  not registered Live/Pending | Williams-Levy, Temmora 2023-03-07 | 
|  KARMA  97649380  not registered Live/Pending | Mars, Incorporated 2022-10-26 | 
|  KARMA  90886955  not registered Live/Pending | Karma Food Group LLC 2021-08-17 | 
|  KARMA  90515476  not registered Live/Pending | Stephen Joseph, Inc. 2021-02-06 | 
|  KARMA  90496825  not registered Live/Pending | Mars, Incorporated 2021-01-29 | 
|  KARMA  90398349  not registered Live/Pending | Custom Orchards, Inc. 2020-12-21 | 
|  KARMA  90392669  not registered Live/Pending | Intrepid Brands, LLC 2020-12-18 | 
|  KARMA  90224178  not registered Live/Pending | Shoptagr Ltd. 2020-09-30 |