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510(k) K101364

LANX FACET SCREW SYSTEM by Lanx, Inc. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2010
Date Received
May 14, 2010
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 Lanx, Inc.

  • K131547 — LANX FUSION SYSTEM (July 12, 2013)
  • K131156 — LANX SPINAL FIXATION SYSTEM (May 24, 2013)
  • K123767 — LANX FUSION SYSTEM- SA (March 18, 2013)
  • K121316 — LANX SPINAL FIZATION SYSTEM (September 10, 2012)
  • K122145 — LANX SPINAL FIXATION SYSTEM (August 17, 2012)
  • K121940 — LANX SPINAL FIXATION SYSTEM (August 2, 2012)
  • K120399 — LANX SPINAL FIXATION SYSTEM (March 9, 2012)
  • K113434 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (December 19, 2011)
  • K112388 — LANX CERVICAL SA (December 16, 2011)
  • K103091 — LANX SPINAL FIXATION SYSTEM (April 15, 2011)

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)
  • K242527 — The Karma® Fixation System (May 21, 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)