Good afternoon-
Im reaching out for opinion on whether to file a Traditional 510(k) or Special 510(k).
Our device, which has been cleared, includes Bone Screws. The Bone Screws are single use devices (consumables).
Because these Bone Screws are "Consumables", we would like to supply replacement Bone Screws to our customers as required.
To do this we need to submit a separate 510(k) to the FDA for only the bone screws.
Since there would be no change in technology or Indications, we feel Special 510(k) would be sufficient.
Thanks for your guidance.
Im reaching out for opinion on whether to file a Traditional 510(k) or Special 510(k).
Our device, which has been cleared, includes Bone Screws. The Bone Screws are single use devices (consumables).
Because these Bone Screws are "Consumables", we would like to supply replacement Bone Screws to our customers as required.
To do this we need to submit a separate 510(k) to the FDA for only the bone screws.
Since there would be no change in technology or Indications, we feel Special 510(k) would be sufficient.
Thanks for your guidance.