510(k) K211704 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer Syste
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Aug 31, 2021 |
| Received | Jun 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211704
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.