510(k) K203576 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
FORZA Ti Spacer System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Mar 3, 2021 |
| Received | Dec 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Orthofix U.S. LLC Brand Name: Forza" Ti Spacer System
Product Name: Forza" Ti Spacer System
Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 6H;
38-2007SP FORZA Ti Spacer, Straight, 0, 9W x 23L Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.