Amendia Stand-Alone Cervical System

• • Terminated Z-0316-2018 FDA Class II ·initiated 7 Jul 2017

  Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.

• • Terminated Z-0966-2017 FDA Class II ·initiated 22 Nov 2016

  Absent tantalum market pin.

510(k) Number

K152972 ↗

FDA Product Code

OVE

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Amendia Interbody Fusion Devices

  Class II

  FDA 510(k) K151310 Active Cleared 6 Jan 2016

• Syzygy Stabilization System

  Class II

  FDA 510(k) K153152 Active Cleared 27 Apr 2016

• Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-Link

  Class II

  FDA 510(k) K132925 Active Cleared 11 Feb 2014

• Spartan S3 Facet System

  Unclassified

  FDA 510(k) K092568 Active Cleared 17 Nov 2009

• Optimus ALIF System

  Class II

  FDA 510(k) K160291 Active Cleared 18 Feb 2016

• Amendia Cervical Plate System

  Class II

  FDA 510(k) K152455 Active Cleared 15 Oct 2015

See all devices from Amendia, Inc. →