510(k) K242527

The Karma® Fixation System by Spinal Elements, Inc. — Product Code MRW

K242527 is an FDA 510(k) premarket notification submitted by Spinal Elements, Inc. for the device "The Karma® Fixation System". The FDA issued a decision of Substantially Equivalent on May 21, 2025. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Spinal Elements, Inc. has at least 10 other 510(k) clearances on record.