510(k) K112316 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
| Applicant | 4-Web, Inc., Apple Valley MN, US |
| Decision | Substantially Equivalent, Dec 14, 2011 |
| Received | Aug 11, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112316
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | 4-Web Inc. ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (ort Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.