Cleared Traditional

The Karma? Fixation System

K242527 · Spinal Elements, Inc. · Orthopedic
May 2025
Decision
268d
Days
—
Risk

About This 510(k) Submission

K242527 is an FDA 510(k) clearance for the The Karma? Fixation System, a System, Facet Screw Spinal Device, submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 21, 2025, 268 days after receiving the submission on August 26, 2024. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K242527 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2024
Decision Date May 21, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MRW — System, Facet Screw Spinal Device
Device Class —