510(k) K203342 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
CONSTRUX Mini Ti Spacer System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Mar 18, 2021 |
| Received | Nov 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Orthofix U.S. LLC Brand Name: CONSTRUX" Mini Ti Spacer System
Product Name: CONSTRUX" Mini Ti Spacer System
Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic
37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordo Open, Classified |
ODP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.