Amendia, Inc.
Medical device manufacturer in Marietta, GA.
16510(k) clearances
0PMA approvals
11recalls
Device types
- NKB Thoracolumbosacral Pedicle Screw System 4
- MAX Intervertebral Fusion Device With Bone… 4
- MRW System, Facet Screw Spinal Device 2
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- MBI Fastener, Fixation, Nondegradable, Soft… 1
- MQP Spinal Vertebral Body Replacement Device 1
- OVE Intervertebral Fusion Device With… 1
- OVD Intervertebral Fusion Device With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K160924 | Amendia Interbody Fusion DevicesMAX · Traditional | 11/08/2016SE |
| K161842 | Overwatch Spine SystemNKB · Traditional | 10/13/2016SE |
| K152920 | Savannah-T® Pedicle Screw SystemNKB · Traditional | 07/08/2016SE |
| K153152 | Syzygy Stabilization SystemNKB · Traditional | 04/27/2016SE |
| K160291 | Optimus ALIF SystemOVD · Special | 02/18/2016SE |
| K152972 | Amendia Stand-Alone Cervical SystemOVE · Traditional | 01/14/2016SE |
| K151310 | Amendia Interbody Fusion DevicesMAX · Traditional | 01/06/2016SE |
| K152460 | Rectangular Corpectomy CageMQP · Traditional | 12/22/2015SE |
| K152455 | Amendia Cervical Plate SystemKWQ · Traditional | 10/15/2015SE |
| K151322 | Amendia Interbody Fusion DevicesMAX · Traditional | 09/10/2015SE |
| K150395 | Omega LIF SystemMAX · Traditional | 08/10/2015SE |
| K133036 | Apollo Suture Anchor System and Titan ScrewsMBI · Traditional | 03/06/2014SE |
| K132925 | Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…NKB · Traditional | 02/11/2014SE |
| K113011 | Spartan S3 Facet SystemMRW · Special | 12/06/2011SE |
| K100265 | Diamond Anterior Cervical Plate SystemKWQ · Traditional | 05/13/2010SE |
| K092568 | Spartan S3 Facet SystemMRW · Traditional | 11/17/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0325-2018 Class II | Mac Pin Non-Cannulated Screw, 6.5 x 60mmIncorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60… | 07/07/2017Terminated |
| Z-0316-2018 Class II | Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling…Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable… | 07/07/2017Terminated |
| Z-1885-2017 Class II | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material:…Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually… | 04/06/2017Terminated |
| Z-0966-2017 Class II | Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical…Absent tantalum market pin. | 11/22/2016Terminated |
| Z-0891-2017 Class II | Optimus Fixed AwlComplaints that the tip of the awl broke after impaction during surgery. | 11/22/2016Terminated |
| Z-0887-2017 Class II | Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part…There is a problem with the mating feature between the plate and screw which could cause the plate opening… | 11/22/2016Terminated |
| Z-0886-2017 Class II | Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part…There is a problem with the mating feature between the plate and screw which could cause the plate opening… | 11/22/2016Terminated |
| Z-0883-2017 Class II | Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm…The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is… | 11/22/2016Terminated |
| Z-0882-2017 Class II | Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the…The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is… | 11/22/2016Terminated |
| 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…The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is… | 11/22/2016Terminated |
| Z-0827-2017 Class II | Zeus-P Lumbar Interbody DeviceLabeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation… | 11/22/2016Terminated |