Irene, ZA · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JEY | Plate, Bone | Class II | Dental | 1 | 2025-12-19 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2023-08-14 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2023-08-14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 1 | 2023-06-13 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2022-12-08 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 1 | 2022-10-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-19 | K253373 | Southern Craniomaxillofacial (CMF) System | JEY | Class II | Dental |
| 2023-08-14 | K230608 | SPICCA Stand-Alone Cervical Fusion Cages | OVE | Class II | Orthopedic |
| 2023-08-14 | K230607 | SPICCA Cervical Fusion Cages | ODP | Class II | Orthopedic |
| 2023-06-13 | K231145 | Axis Anterior Cervical Plate System | KWQ | Class II | Orthopedic |
| 2022-12-08 | K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | MAX | Class II | Orthopedic |
| 2022-10-14 | K221447 | Southern Anterior Screw Fixated Cage (SASCA) | OVD | Class II | Orthopedic |