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510(k) K242527

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2025
Date Received
August 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Facet Screw Spinal Device
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Spinal Elements, Inc.

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  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)
  • K243916 — Primus Spinal Fixation System (February 21, 2025)
  • K234150 — Lucent® XP (March 27, 2024)
  • K231593 — Sapphire X3 Anterior Cervical Plate System (August 2, 2023)
  • K231252 — Ventana™ L Spinal System (June 30, 2023)
  • K222833 — Ventana™ C Spinal System (May 19, 2023)
  • K222516 — Mercury® II Spinal System (December 1, 2022)
  • K210044 — Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal S (June 30, 2021)
  • K203254 — Lucent 3D Spinal System (March 26, 2021)

Other clearances for product code MRW

  • K251714 — Ion-C (January 16, 2026)
  • K250679 — FFX Facet Fixation System (December 4, 2025)
  • K253190 — CORUS-LX Implant (November 20, 2025)
  • K252153 — FFX Facet Fixation System (October 16, 2025)
  • K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (July 10, 2025)
  • K250920 — Arthrex Spine Compression FT Screw (May 22, 2025)
  • K243865 — AERO MIS Facet Fusion System (March 24, 2025)
  • K243265 — Ion 3D (December 4, 2024)
  • K242650 — zLOCK Lumbar Facet Fixation System (September 20, 2024)
  • K241035 — PMT Posterior Cervical Stabilization System (PCSS) (June 25, 2024)