Posted by Michael Wonder on 08 Dec 2020
Carlsmed aprevo granted unprecedented decision by FDA
8 December 2020 - -Carlsmed today announced it has been granted 510(k) clearance and breakthrough device designation by the FDA for its aprevo patient specific interbody devices for the correction of adult spinal deformity.
The Carlsmed aprevo device is the first implant ever to receive both breakthrough device designation and 510(k) market clearance from the FDA.
