Amendia, Inc

11 devices in the database

  • Model / Serial
    Lot Number 135561
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution to GA, KS & TX
  • Product Description
    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
  • Model / Serial
    Model #85-6560-1, Lot #132117
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution to Georgia, USA.
  • Product Description
    Mac Pin Non-Cannulated Screw, 6.5 x 60mm
  • Model / Serial
    Model # 12-31-4012, Lot #133039
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to states of: AL, FL, GA, NY, TX, and VA.
  • Product Description
    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.
  • Model / Serial
    Part Number TBS020 Lot Number 0825R, NM01836, WT090314A, 09281, 09282, 09285, WT040412A, 08344, 09154, 09281R, NM01836R; Part Number TBS025 Lot Number 09161, 09286R, WT090314B, WT112613B, 08218, 08337, 09287R, NM01837, 08216; Part Number TBS030 Lot Number 08218, WT011711B, WT071014A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to IN, LA, and TX
  • Product Description
    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
  • Model / Serial
    Part Number TBP119  Lot Number WT103014B, WT112210B, 01838, WT111213A, WT040813A, WT042213C; Part Number TB123  Lot Number NM01839, WT080112A, WT081712E, WT112210C, WT112113A, WT112713B, WT110714A, WT1127, 09286, WT041213A, WT112713
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to IN, LA, and TX
  • Product Description
    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
6 more

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    Amendia, Inc dba Spinal Elements, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • Manufacturer Parent Company (2017)
  • Source
    USFDA