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510(k) K113011

SPARTAN S3 FACET SYSTEM by Amendia, Inc. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2011
Date Received
October 11, 2011
Clearance Type
Special
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 Amendia, Inc.

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  • K161842 — Overwatch Spine System (October 13, 2016)
  • K152920 — Savannah-T® Pedicle Screw System (July 8, 2016)
  • K153152 — Syzygy Stabilization System (April 27, 2016)
  • K160291 — Optimus ALIF System (February 18, 2016)
  • K152972 — Amendia Stand-Alone Cervical System (January 14, 2016)
  • K151310 — Amendia Interbody Fusion Devices (January 6, 2016)
  • K152460 — Rectangular Corpectomy Cage (December 22, 2015)
  • K152455 — Amendia Cervical Plate System (October 15, 2015)
  • K151322 — Amendia Interbody Fusion Devices (September 10, 2015)

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)