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    Agendia Inc

    FDA registration
    Agendia Inc·2 products·🇺🇸 United States

    MammaPrint FFPE

    FDA UDI
    Agendia, Inc.·00850024841321·MammaPrint® FFPE is a qualitative, non-automate...

    Agendia MammaPrint, Catalog Numbers MP01, MP US version 03

    FDA Recall
    Terminated ·Agendia Inc·Product code NYI·March 3, 2010

    AMENDIA GUIDEWIRE

    FDA Adverse Event
    Malfunction ·AMENDIA, INC.·Product code DQX·January 12, 2011

    SCREWS

    FDA Adverse Event
    Malfunction ·AMENDIA, INC.·Product code MRW·February 17, 2016

    MAKO IMPLANT

    FDA Adverse Event
    Injury ·AMENDIA, INC.·Product code HWC·July 6, 2010

    Optimus Fixed Awl

    FDA Recall
    Terminated ·Amendia, Inc·Product code OVD·November 22, 2016

    Zeus-P Lumbar Interbody Device

    FDA Recall
    Terminated ·Amendia, Inc·Product code MAX·November 22, 2016

    SAVANNAH-T PEDICLE SCREW SYSTEM

    FDA Adverse Event
    AMENDIA / SPINAL ELEMENTS, INC.·Product code NKB·April 30, 2019

    Wound Management Tray Asoc. Agencia Salud, catalog# 900-1154

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCY·December 8, 2011

    Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.

    FDA Recall
    Terminated ·Amendia, Inc·Product code OVE·July 7, 2017

    Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region

    FDA Recall
    Terminated ·Amendia, Inc·Product code KWQ·November 22, 2016

    Mac Pin Non-Cannulated Screw, 6.5 x 60mm

    FDA Recall
    Terminated ·Amendia, Inc·Product code NKB·July 7, 2017

    Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.

    FDA Recall
    Terminated ·Amendia, Inc·Product code OVE·November 22, 2016

    K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Recall
    Terminated ·Amendia, Inc·Product code HTY·November 22, 2016

    Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Recall
    Terminated ·Amendia, Inc·Product code LXH·November 22, 2016

    Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Recall
    Terminated ·Amendia, Inc·Product code MNH·November 22, 2016

    Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region

    FDA Recall
    Terminated ·Amendia, Inc·Product code KWQ·November 22, 2016

    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery

    FDA Recall
    Terminated ·Amendia, Inc·Product code LXH·April 6, 2017

    Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·January 18, 2017