Replies to post #13965 on SiNtx Technologies Inc (SINT)

[boston745]

My opinion is in my blog. I think they submitted 2 devices late 2016 based on whats described in 10k.

There's this:

In December 2016, we re-filed an FDA 510(k) submission for clearance in the United States of a modified novel composite spinal fusion device that combines porous and solid silicon nitride, and obviates the need for bone grafts that is comparable to our commercially-available Valeo®C cervical implants.

This is Valeo C + CsC with Lumen (hole). Solid Si3N4 otter shell, porous center with a small hole to pack bone into.

Then there is this:

We have since re-filed a 510(k) premarket application with the FDA, for a modified CsC-based cervical implant that is comparable to our own commercially-available Valeo®C cervical implants.

Amedica 2016 10k pg 12

To me there are 2 different devices pending and 1 is the composite we are familiar with and the other is a porous Valeo C with no solid portion which is like Zimmers Ardis TM device. This is the device I believe the LOI is referencing.

See porous fusion blog post