510(k) K093438 ยท KWP Appliance, Fixation, Spinal Interlaminal
PARADIGM INTERSPINOUS FUSION PLATE
| Applicant | Paradigm Spine, LLC, Washington DC, US |
| Decision | Substantially Equivalent, Oct 6, 2010 |
| Received | Nov 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2012 | SpineFrontier, Inc. Spine Frontier Inspan compressors
Part Number: 11-60004.
Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant. Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.