Amendia, Inc.
Amendia, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2016, with 11 FDA device recalls on record.
Top product codes for Amendia, Inc.
FDA recalls by Amendia, Inc.
10 most recent of 11- Z-0316-2018 — 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.
- Z-0325-2018 — Mac Pin Non-Cannulated Screw, 6.5 x 60mm
- Z-1885-2017 — 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
- Z-0966-2017 — 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.
- Z-0887-2017 — 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
- Z-0882-2017 — 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
- Z-0827-2017 — Zeus-P Lumbar Interbody Device
- Z-0886-2017 — 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
- Z-0891-2017 — Optimus Fixed Awl
- Z-0883-2017 — 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Amendia, Inc.
- K160924 — Amendia Interbody Fusion Devices
- K161842 — Overwatch Spine System
- K152920 — Savannah-T® Pedicle Screw System
- K153152 — Syzygy Stabilization System
- K160291 — Optimus ALIF System
- K152972 — Amendia Stand-Alone Cervical System
- K151310 — Amendia Interbody Fusion Devices
- K152460 — Rectangular Corpectomy Cage
- K152455 — Amendia Cervical Plate System
- K151322 — Amendia Interbody Fusion Devices
- K150395 — Omega LIF System
- K133036 — APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
- K132925 — SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK
- K113011 — SPARTAN S3 FACET SYSTEM
- K100265 — DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
- K092568 — SPARTAN S3 FACET SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.