510(k) K101085 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SPINESMITH CYNCH SPINAL SYSTEM
| Applicant | Spine Smith Partners L.P., Austin TX, US |
| Decision | Substantially Equivalent, Jul 1, 2010 |
| Received | Apr 19, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101085
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2013 | Spine Smith Partners LP Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation. Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.