Pear, MS, US · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 2 | 2024-12-17 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 2 | 2023-05-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 2 | 2022-03-16 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2025-11-24 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 1 | 2022-04-01 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2021-12-08 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2021-01-12 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-24 | K250769 | Dakota LP System | ODP | Class II | Orthopedic |
| 2024-12-17 | K242297 | Reform Pedicle Screw System | NKB | Class II | Orthopedic |
| 2023-05-25 | K231229 | S-COMP Reform® POCT Navigation Instruments | OLO | Class II | Neurology |
| 2022-07-14 | K220862 | E-GPS Navigated Instruments | OLO | Class II | Neurology |
| 2022-04-01 | K213118 | Dakota ALIF System | OVD | Class II | Orthopedic |
| 2022-03-16 | K220324 | AccuFit Lateral 2-Hole Plate | KWQ | Class II | Orthopedic |
| 2021-12-08 | K212075 | ShurFit Lumbar Interbody System | MAX | Class II | Orthopedic |
| 2021-11-04 | K212937 | Dakota ALIF Plate System | KWQ | Class II | Orthopedic |
| 2021-01-12 | K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | OVE | Class II | Orthopedic |
| 2020-05-19 | K200303 | Reform Pedicle Screw System | NKB | Class II | Orthopedic |