| Primary Device ID | 00842048185482 |
| NIH Device Record Key | 50a1818e-b898-40fd-a185-6d53831979b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Latitude-C AM™ Cervical Interbody Fusion System |
| Version Model Number | 0306-181412L16 |
| Catalog Number | 0306-181412L16 |
| Company DUNS | 078812602 |
| Company Name | DEGEN MEDICAL, INC. |
| 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 | true |
| 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(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842048185482 [Primary] |
| ODP | Intervertebral fusion device with bone graft, cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-02 |
| Device Publish Date | 2025-11-24 |
| 00842048197324 | 18W X 14D X 14H X 0° Latitude-C AM™ Modular Trial |
| 00842048197317 | 18W X 14D X 13H X 0° Latitude-C AM™ Modular Trial |
| 00842048197300 | 18W X 14D X 12H X 0° Latitude-C AM™ Modular Trial |
| 00842048197294 | 18W X 14D X 11H X 0° Latitude-C AM™ Modular Trial |
| 00842048197287 | 18W X 14D X 10H X 0° Latitude-C AM™ Modular Trial |
| 00842048196488 | 18W X 14D X 14H X 16° Latitude-C AM™ Modular Trial |
| 00842048196471 | 18W X 14D X 13H X 16° Latitude-C AM™ Modular Trial |
| 00842048196464 | 18W X 14D X 12H X 16° Latitude-C AM™ Modular Trial |
| 00842048196457 | 18W X 14D X 11H X 16° Latitude-C AM™ Modular Trial |
| 00842048196440 | 18W X 14D X 10H X 16° Latitude-C AM™ Modular Trial |
| 00842048195733 | 18W X 14D X 14H X 12° Latitude-C AM™ Modular Trial |
| 00842048195726 | 18W X 14D X 13H X 12° Latitude-C AM™ Modular Trial |
| 00842048195719 | 18W X 14D X 12H X 12° Latitude-C AM™ Modular Trial |
| 00842048195702 | 18W X 14D X 11H X 12° Latitude-C AM™ Modular Trial |
| 00842048195696 | 18W X 14D X 10H X 12° Latitude-C AM™ Modular Trial |
| 00842048194941 | 20W X 12D X 9H X 8° Latitude-C AM™ Modular Trial |
| 00842048194934 | 20W X 12D X 8H X 8° Latitude-C AM™ Modular Trial |
| 00842048194927 | 20W X 12D X 7H X 8° Latitude-C AM™ Modular Trial |
| 00842048194910 | 20W X 12D X 6H X 8° Latitude-C AM™ Modular Trial |
| 00842048194903 | 20W X 12D X 5H X 8° Latitude-C AM™ Modular Trial |
| 00842048194897 | 18W X 14D X 14H X 8° Latitude-C AM™ Modular Trial |
| 00842048194880 | 18W X 14D X 13H X 8° Latitude-C AM™ Modular Trial |
| 00842048194873 | 18W X 14D X 12H X 8° Latitude-C AM™ Modular Trial |
| 00842048194866 | 18W X 14D X 11H X 8° Latitude-C AM™ Modular Trial |
| 00842048194859 | 18W X 14D X 10H X 8° Latitude-C AM™ Modular Trial |
| 00842048194743 | 18W X 12D X 9H X 8° Latitude-C AM™ Modular Trial |
| 00842048194736 | 18W X 12D X 8H X 8° Latitude-C AM™ Modular Trial |
| 00842048194729 | 18W X 12D X 7H X 8° Latitude-C AM™ Modular Trial |
| 00842048193999 | 18W X 14D X 14H X 4° Latitude-C AM™ Modular Trial |
| 00842048193982 | 18W X 14D X 13H X 4° Latitude-C AM™ Modular Trial |
| 00842048193975 | 18W X 14D X 12H X 4° Latitude-C AM™ Modular Trial |
| 00842048193968 | 18W X 14D X 11H X 4° Latitude-C AM™ Modular Trial |
| 00842048193951 | 18W X 14D X 10H X 4° Latitude-C AM™ Modular Trial |
| 00842048193197 | 18W X 14D X 14H Latitude-C AM™ Anatomic Modular Trial |
| 00842048193180 | 18W X 14D X 13H Latitude-C AM™ Anatomic Modular Trial |
| 00842048193173 | 18W X 14D X 12H Latitude-C AM™ Anatomic Modular Trial |
| 00842048193166 | 18W X 14D X 11H Latitude-C AM™ Anatomic Modular Trial |
| 00842048193159 | 18W X 14D X 10H Latitude-C AM™ Anatomic Modular Trial |
| 00842048187240 | 18W X 14D X 14H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187233 | 18W X 14D X 13H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187226 | 18W X 14D X 12H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187219 | 18W X 14D X 11H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187202 | 18W X 14D X 10H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187042 | 16W X 14D X 14H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187035 | 16W X 14D X 13H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187028 | 16W X 14D X 12H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187011 | 16W X 14D X 11H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048187004 | 16W X 14D X 10H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048186991 | 16W X 14D X 9H Anatomic Latitude-C AM™ Cervical Spacer |
| 00842048186984 | 16W X 14D X 8H Anatomic Latitude-C AM™ Cervical Spacer |