| Primary Device ID | 00840606154291 | 
| NIH Device Record Key | 2c496c27-e200-4647-8306-d0b0e7610e59 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Katana | 
| Version Model Number | 80012-000-01 | 
| 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 | 00840606154291 [Primary] | 
| OJH | Orthopedic Tray | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
Moist Heat or Steam Sterilization
[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
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[00840606154291]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-11-20 | 
| Device Publish Date | 2019-11-12 | 
| 00840606154321 | KATANA TM ARM TRAY TOP INSERT | 
| 00840606154314 | KATANA TM ARM TRAY BOTTOM INSERT | 
| 00840606154307 | KATANA TM ARM TRAY LID | 
| 00840606154291 | KATANA TM ARM TRAY BASE | 
| 00840606154284 | KATANA TM ARM TRAY ASSEMBLY | 
| 00840606161855 | LUCENT® L KATANA CENTER BLADE, 180MM | 
| 00840606161848 | LUCENT® L KATANA CENTER BLADE, 170MM | 
| 00840606161831 | LUCENT® L KATANA CENTER BLADE, 160MM | 
| 00840606161824 | LUCENT® L KATANA CENTER BLADE, 150MM | 
| 00840606161817 | LUCENT® L KATANA CENTER BLADE, 140MM | 
| 00840606161800 | LUCENT® L KATANA CENTER BLADE, 130MM | 
| 00840606161794 | LUCENT® L KATANA CENTER BLADE, 120MM | 
| 00840606161787 | LUCENT® L KATANA CENTER BLADE, 110MM | 
| 00840606161770 | LUCENT® L KATANA CENTER BLADE, 100MM | 
| 00840606161763 | LUCENT® L KATANA CENTER BLADE, 90MM | 
| 00840606161756 | LUCENT® L KATANA CENTER BLADE, 80MM | 
| 00840606184830 | Posterior Access Guide, SS | 
| 00840606184823 | Anterior Access Guide, SS | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  KATANA  98891964  not registered Live/Pending | Q.E.P. Co., Inc 2024-12-09 | 
|  KATANA  97615101  not registered Live/Pending | Synaptics Incorporated 2022-09-30 | 
|  KATANA  97539602  not registered Live/Pending | ANEST IWATA Corporation 2022-08-08 | 
|  KATANA  97393328  not registered Live/Pending | Kirchner Brands Inc. 2022-05-03 | 
|  KATANA  97064538  not registered Live/Pending | TrellisWare Technologies, Inc. 2021-10-07 | 
|  KATANA  97015001  not registered Live/Pending | Fender Musical Instruments Corporation 2021-09-07 | 
|  KATANA  90867444  not registered Live/Pending | LARTNOW, LLC 2021-08-05 | 
|  KATANA  90754243  not registered Live/Pending | Koike Aronson, Inc. 2021-06-04 | 
|  KATANA  90533857  not registered Live/Pending | KUREHA CORPORATION 2021-02-18 | 
|  KATANA  90509919  not registered Live/Pending | FUJI SHOKO CO., LTD. 2021-02-04 | 
|  KATANA  90156281  not registered Live/Pending | Katana Technologies OÃ 2020-09-03 | 
|  KATANA  90129881  not registered Live/Pending | Roland Corporation 2020-08-21 |