510(k) K172437 · ODP Intervertebral Fusion Device With Bone Graft, Cervical
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Nov 2, 2017 |
| Received | Aug 11, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172437
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Orthofix U.S. LLC Brand Name: CONSTRUX" Mini PTC Spacer System
Product Name: CONSTRUX" Mini PTC Spacer System
Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel;
37-3107SP 12mm W X 12mm L, 7mm H, Parall Open, Classified |
ODP | None listed |
| Dec 11, 2025 | Orthofix U.S. LLC Brand Name: FORZA" PTC Spacer System
Product Name: FORZA" PTC Spacer System
Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H
38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 2 Open, Classified |
MAX | None listed |
| Dec 11, 2025 | Orthofix U.S. LLC Brand Name: Pillar" SA PTC Spacer System
Product Name: Pillar" SA PTC Spacer System
Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT;
39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT;
39 Open, Classified |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.