Amendia, Inc
FDA Regulatory Profile
Amendia, Inc appears in FDA public data with 11 recalls, 16 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0325-2018, Class II) was initiated on July 7, 2017. Its most recent 510(k) clearance was granted on November 8, 2016.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 16
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0325-2018 | Class II | Mac Pin Non-Cannulated Screw, 6.5 x 60mm | July 7, 2017 |
| Z-0316-2018 | Class II | Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws | July 7, 2017 |
| Z-1885-2017 | Class II | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Fu | April 6, 2017 |
| Z-0891-2017 | Class II | Optimus Fixed Awl | November 22, 2016 |
| Z-0827-2017 | Class II | Zeus-P Lumbar Interbody Device | November 22, 2016 |
| Z-0966-2017 | Class II | Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fu | November 22, 2016 |
| Z-0883-2017 | Class II | Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 1 | November 22, 2016 |
| Z-0881-2017 | Class II | K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080 | November 22, 2016 |
| Z-0886-2017 | Class II | Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 | November 22, 2016 |
| Z-0887-2017 | Class II | Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS0 | November 22, 2016 |
| Z-0882-2017 | Class II | Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle o | November 22, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160924 | Amendia Interbody Fusion Devices | November 8, 2016 |
| K161842 | Overwatch Spine System | October 13, 2016 |
| K152920 | Savannah-T® Pedicle Screw System | July 8, 2016 |
| K153152 | Syzygy Stabilization System | April 27, 2016 |
| K160291 | Optimus ALIF System | February 18, 2016 |
| K152972 | Amendia Stand-Alone Cervical System | January 14, 2016 |
| K151310 | Amendia Interbody Fusion Devices | January 6, 2016 |
| K152460 | Rectangular Corpectomy Cage | December 22, 2015 |
| K152455 | Amendia Cervical Plate System | October 15, 2015 |
| K151322 | Amendia Interbody Fusion Devices | September 10, 2015 |
| K150395 | Omega LIF System | August 10, 2015 |
| K133036 | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS | March 6, 2014 |
| K132925 | SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAV | February 11, 2014 |
| K113011 | SPARTAN S3 FACET SYSTEM | December 6, 2011 |
| K100265 | DIAMOND ANTERIOR CERVICAL PLATE SYSTEM | May 13, 2010 |
| K092568 | SPARTAN S3 FACET SYSTEM | November 17, 2009 |