| Primary Device ID | 00840606184816 |
| NIH Device Record Key | 1766c060-cc4a-4462-9894-9c396f8a9f42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multiple |
| Version Model Number | 10000-999 |
| Company DUNS | 610712213 |
| Company Name | SPINAL ELEMENTS, INC. |
| 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 | 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 | 00840606184816 [Primary] |
| OJH | Orthopedic Tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
[00840606184816]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-17 |
| Device Publish Date | 2024-05-09 |
| 00840606184823 - Katana | 2025-05-29 Anterior Access Guide, SS |
| 00840606184830 - Katana | 2025-05-29 Posterior Access Guide, SS |
| 00840606187497 - Overwatch | 2025-05-22 Overwatch Slotted Axial Reducer |
| 00840606187510 - LOTUS | 2025-05-05 Lotus® ø4.0mm Polyaxial Screw Caddy |
| 00840606184953 - Lucent Lateral | 2025-05-02 ANTERIOR EXTENSION, 10MM |
| 00840606184960 - Lucent Lateral | 2025-05-02 ANTERIOR EXTENSION, 12MM |
| 00840606184977 - Lucent Lateral | 2025-05-02 ANTERIOR EXTENSION, 14MM |
| 00840606184984 - Lucent Lateral | 2025-05-02 ANTERIOR EXTENSION, 16MM |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MULTIPLE 98361511 not registered Live/Pending |
FBA Private Market, LLC 2024-01-17 |
![]() MULTIPLE 98017886 not registered Live/Pending |
PRL Inc. 2023-05-29 |
![]() MULTIPLE 85965618 4881951 Live/Registered |
Multiple, Inc. 2013-06-20 |
![]() MULTIPLE 85347383 4418998 Live/Registered |
Universal Cooperatives, Inc. 2011-06-15 |
![]() MULTIPLE 85317632 not registered Dead/Abandoned |
LING-LING PAN 2011-05-11 |
![]() MULTIPLE 75300895 2369683 Dead/Cancelled |
Iwata Denko Co., Ltd. 1997-05-30 |