510(k) K240749 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
PILLAR SA Ti Spacer System (82-XXX)
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, May 28, 2024 |
| Received | Mar 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240749
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2025 | Orthofix U.S. LLC PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP Open, Classified |
MAX | None listed |
| Mar 21, 2025 | Orthofix U.S. LLC Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:
(1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees;
(2) REF 82-3700SP, 37mm W Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.