Home / 510(k) Clearances / K152455

510(k) K152455

Amendia Cervical Plate System by Amendia, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2015
Date Received
August 28, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Amendia, Inc.

  • K160924 — Amendia Interbody Fusion Devices (November 8, 2016)
  • 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)
  • K151322 — Amendia Interbody Fusion Devices (September 10, 2015)
  • K150395 — Omega LIF System (August 10, 2015)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)