Home » SMAIO Gets FDA Clearance for Its Balance Analyzer 3D Surgery Planning Software
SMAIO Gets FDA Clearance for Its Balance Analyzer 3D Surgery Planning Software
Devices Submissions and Approvals
France-based SMAIO has received 510(k) clearance from the FDA for its Balance Analyzer 3D surgery planning software.
The spinal realignment planning software, which assesses images of the patient’s spine, is part of the company’s i-kontrol platform for spinal surgery.
SMAIO is an acronym for Software, Machines and Adaptative Implants in Orthopedics. The company specializes in devices for complex spinal surgery, including software, adaptative implants and related services.
The Balance Analyzer 3D software earned a CE mark certification in 2014.