- Quick summary of certifications and registrations*:
- Biologics Registrations with: AATB, CLIA, CTO Canada, FDA, Health Canada Device, ISO 13485
- Fixation Registrations with: FDA 21 CFR Part 820, European Medical Device Directive, ISO 13485:2003 (BSI Registrar)
* For copies of current certifications and registrations, go to Licenses and Certifications, Resources.
- Quick Reference of 510ks:
- Aranax 510k K150834
- Axle 510k K101471, K112592, K130438
- Butrex 510k K072943
- Calix 510k K131350
- Calix PC 510k K112036
- Certex 510k K160428
- Fixcet 510k K100154
- Fortex 510k K120832
- Irix-A 510k K133947
- Irix-C 510k K162944
- OsteoSelect 510k K130498
- OsteoSelect PLUS 510k K150621
- Silex 510k K140079
- Spider 510k K052292
- X90 510k K052847
- Xspan 510k K160114
- Xpress 510k K152132
- Zyfix 510k K123932
- How do I return products?
- Contact Customer Care for a return authorization and return instructions: cs@xtantmedical.com
- How do I get a consignment agreement in place?
- Contact your local representative, or email nationalaccounts@xtantmedical.com.