FDA Grants SpineGuard 510(k) Clearance for 3 Versions of PediGuard Platform

San Francisco-based SpineGuard received FDA 510(k) clearance for three products to complete its PediGuard platform of single-use drilling instruments for pedicle screw pilot holes. Clearance was granted to two miniature versions of the classic and curved range, as well as a directional version of its cannulated series.

The mini PediGuard sensor allows for small-size applications, such as drill bits, guide wires or implants. The platform is designed to increase pedicle screw placement accuracy.

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