510(k) K152501 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Spinal Jaxx Interbody Fusion Device
| Applicant | Neuropro Spinaljaxx, Inc., Modesto CA, US |
| Decision | Substantially Equivalent, Jun 29, 2016 |
| Received | Sep 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152501
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2018 | Neuropro Spinal Jaxx Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L
Product Usage:
The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative di Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.