Amendia, Inc

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0325-2018Class IIMac Pin Non-Cannulated Screw, 6.5 x 60mmJuly 7, 2017
Z-0316-2018Class IICeres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws July 7, 2017
Z-1885-2017Class II01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, FuApril 6, 2017
Z-0827-2017Class IIZeus-P Lumbar Interbody DeviceNovember 22, 2016
Z-0886-2017Class IIBlack Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 November 22, 2016
Z-0966-2017Class IICeres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fuNovember 22, 2016
Z-0881-2017Class IIK-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080November 22, 2016
Z-0891-2017Class IIOptimus Fixed AwlNovember 22, 2016
Z-0883-2017Class IISavannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 1November 22, 2016
Z-0887-2017Class IIBlack Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS0November 22, 2016
Z-0882-2017Class IIDual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle oNovember 22, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K160924Amendia Interbody Fusion DevicesNovember 8, 2016
K161842Overwatch Spine SystemOctober 13, 2016
K152920Savannah-T® Pedicle Screw SystemJuly 8, 2016
K153152Syzygy Stabilization SystemApril 27, 2016
K160291Optimus ALIF SystemFebruary 18, 2016
K152972Amendia Stand-Alone Cervical SystemJanuary 14, 2016
K151310Amendia Interbody Fusion DevicesJanuary 6, 2016
K152460Rectangular Corpectomy CageDecember 22, 2015
K152455Amendia Cervical Plate SystemOctober 15, 2015
K151322Amendia Interbody Fusion DevicesSeptember 10, 2015
K150395Omega LIF SystemAugust 10, 2015
K133036APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWSMarch 6, 2014
K132925SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVFebruary 11, 2014
K113011SPARTAN S3 FACET SYSTEMDecember 6, 2011
K100265DIAMOND ANTERIOR CERVICAL PLATE SYSTEMMay 13, 2010
K092568SPARTAN S3 FACET SYSTEMNovember 17, 2009