510(k) K193359 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
SureMAX Family of Cervical Spacers
| Applicant | Additive Implants, Inc., Phoenix AZ, US |
| Decision | Substantially Equivalent, Jan 3, 2020 |
| Received | Dec 4, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193359
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.