510(k) K191537 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
eCarbon IBDs
| Applicant | Back 2 Basics Direct, LLC, Independence OH, US |
| Decision | Substantially Equivalent, Sep 26, 2019 |
| Received | Jun 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191537
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.