Solo Pace Fusion System (SOLOFUSE1)

Solo Pace Fusion System (SOLOFUSE1) is an FDA 510(k)-cleared medical device (K252674) manufactured by Solo Pace, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 8, 2026. Regulation: 8.