Titan Medical Inc (TMDIF)

[chillout]

510K or PMA depend upon classification.
Example: approval has to do with pre market application, such as an implantable. 510K or clearance has to do with premarket notification. i.e. robotics.
Sorry for the curt response, however, I think we get away from the end goal and discussion. Especially from some posters that like to muddy the waters from other boards supporting inferior comparisons.