Flowood, MS, US · 19 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 6 | 2024-04-10 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 5 | 2026-07-24 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | 2 | 2023-01-18 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2023-07-12 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 1 | 2023-06-14 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2022-08-12 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | 1 | 2021-08-11 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2021-01-29 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 1 | 2020-11-04 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-24 | K253943 | Tiger 2 System | NKB | Class II | Orthopedic |
| 2025-02-03 | K243908 | Tiger 2 System | NKB | Class II | Orthopedic |
| 2024-04-10 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | MAX | Class II | Orthopedic |
| 2023-08-22 | K231811 | Zavation Connector System | NKB | Class II | Orthopedic |
| 2023-07-12 | K223808 | Zavation Navigation Instrument System | OLO | Class II | Neurology |
| 2023-06-14 | K230731 | Zavation ALIF System | OVD | Class II | Orthopedic |
| 2023-01-18 | K221726 | Uni-FuZe-C Bone Strip | MQV | Class II | Orthopedic |
| 2022-12-05 | K222614 | Zavation Spinal System | NKB | Class II | Orthopedic |
| 2022-08-12 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | OVE | Class II | Orthopedic |
| 2022-06-02 | K220581 | Zavation eZspand Interbody System | MAX | Class II | Orthopedic |
| 2022-04-12 | K212811 | Ti3Z Lumbar Interbody System | MAX | Class II | Orthopedic |
| 2021-08-11 | K211993 | Z-LINKPC System | NKG | Class II | Orthopedic |
| 2021-07-12 | K211113 | Zavation Spinal System | NKB | Class II | Orthopedic |
| 2021-06-24 | K211306 | LABYRINTH | MAX | Class II | Orthopedic |
| 2021-01-29 | K202398 | Ti3Z Cervical Interbody System | ODP | Class II | Orthopedic |
| 2020-12-28 | K201781 | Uni-FuZe-P Bone Putty | MQV | Class II | Orthopedic |
| 2020-11-04 | K202624 | Z-Span Plate System | KWQ | Class II | Orthopedic |
| 2020-10-19 | K200084 | Zavation IBF System | MAX | Class II | Orthopedic |
| 2020-10-13 | K202305 | Zavation IBF System | MAX | Class II | Orthopedic |