Carlsmed aprevo Interbody Gains FDA Clearance, Breakthrough Device Designation

CARLSMED aprevo Implant

Carlsmed was granted FDA 510(k) clearance and Breakthrough Device Designation by FDA for aprevo™ patient-specific interbody devices for the correction of adult spinal deformity. The Carlsmed aprevo device is reportedly the first implant ever to receive both Breakthrough Device Designation and 510(k) market clearance from FDA.

To meet the...

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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