Company · US
Amendia, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2016. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 |
| NKB | Thoracolumbosacral Pedicle Screw System | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 3 |
| LXH | Orthopedic Manual Surgical Instrument | 2 |
| MRW | System, Facet Screw Spinal Device | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 |
| HTY | Pin, Fixation, Smooth | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 8, 2016 | K160924 | Amendia Interbody Fusion Devices Amendia, Inc. | MAX |
| Oct 13, 2016 | K161842 | Overwatch Spine System Amendia, Inc. | NKB |
| Jul 8, 2016 | K152920 | Savannah-T® Pedicle Screw System Amendia, Inc. | NKB |
| Apr 27, 2016 | K153152 | Syzygy Stabilization System Amendia, Inc. | NKB |
| Feb 18, 2016 | K160291 | Optimus ALIF System Amendia, Inc. | OVD |
| Jan 14, 2016 | K152972 | Amendia Stand-Alone Cervical System Amendia, Inc. | OVE |
| Jan 6, 2016 | K151310 | Amendia Interbody Fusion Devices Amendia, Inc. | MAX |
| Dec 22, 2015 | K152460 | Rectangular Corpectomy Cage Amendia, Inc. | MQP |
| Oct 15, 2015 | K152455 | Amendia Cervical Plate System Amendia, Inc. | KWQ |
| Sep 10, 2015 | K151322 | Amendia Interbody Fusion Devices Amendia, Inc. | MAX |
| Aug 10, 2015 | K150395 | Omega LIF System Amendia, Inc. | MAX |
| Mar 6, 2014 | K133036 | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS Amendia, Inc. | MBI |
| Feb 11, 2014 | K132925 | SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK Amendia, Inc. | NKB |
| Dec 6, 2011 | K113011 | SPARTAN S3 FACET SYSTEM Amendia, Inc. | MRW |
| May 13, 2010 | K100265 | DIAMOND ANTERIOR CERVICAL PLATE SYSTEM Amendia, Inc. | KWQ |
| Nov 17, 2009 | K092568 | SPARTAN S3 FACET SYSTEM Amendia, Inc. | MRW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2017 | Amendia, Inc Mac Pin Non-Cannulated Screw, 6.5 x 60mm Terminated |
NKB | K153152 |
| Jul 7, 2017 | Amendia, Inc 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. Terminated |
OVE | K152972 |
| Apr 25, 2017 | Amendia, Inc 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 Terminated |
LXH | None listed |
| Jan 9, 2017 | Amendia, Inc 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 Terminated |
OVE | K152972 |
| Dec 22, 2016 | Amendia, Inc 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 ar Terminated |
KWQ | K081770 |
| Dec 22, 2016 | Amendia, Inc 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 all Terminated |
KWQ | K081770 |
| Dec 22, 2016 | Amendia, Inc Optimus Fixed Awl Terminated |
OVD | K132596 |
| Dec 20, 2016 | Amendia, Inc Zeus-P Lumbar Interbody Device Terminated |
MAX | K151322 |
| Nov 22, 2016 | Amendia, Inc 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 Terminated |
MNH | K132925 K152920 +2 |
| Nov 22, 2016 | Amendia, Inc 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 Terminated |
LXH | None listed |
| Nov 22, 2016 | Amendia, Inc 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 Num Terminated |
HTY | None listed |