Redlands, CA, US · 16 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 4 | 2026-07-15 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | 3 | 2021-04-02 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 2 | 2025-04-10 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 2 | 2025-03-20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 1 | 2025-04-10 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 1 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 1 | 2024-11-05 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | 1 | 2024-04-04 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | 1 | 2020-04-17 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-15 | K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | OVD | Class II | Orthopedic |
| 2025-04-10 | K242928 | Tesera-k SC System | OVE | Class II | Orthopedic |
| 2025-04-10 | K242045 | Initia T3 Acetabular Hemispherical Shell System | LPH | Class II | Orthopedic |
| 2025-03-20 | K242771 | Tesera-k PL System and Tesera-k XL System | MAX | Class II | Orthopedic |
| 2025-01-13 | K243295 | Initia Knee System | JWH | Class II | Orthopedic |
| 2024-11-05 | K243015 | Skyway Anterior Cervical Plate System | KWQ | Class II | Orthopedic |
| 2024-04-04 | K232114 | TRIBRID® Unicompartmental Knee System | HSX | Class II | Orthopedic |
| 2023-04-21 | K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | Class II | Orthopedic |
| 2022-12-22 | K223105 | Tesera-K SC System | OVE | Class II | Orthopedic |
| 2022-01-07 | K212980 | Tesera-k ALIF System | OVD | Class II | Orthopedic |
| 2021-08-30 | K212070 | KMTI S141 Lumbar Interbody Fusion System | MAX | Class II | Orthopedic |
| 2021-04-02 | K203472 | KMTI Hip Replacement System | OQG | Class II | Orthopedic |
| 2020-07-16 | K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | OQG | Class II | Orthopedic |
| 2020-04-17 | K200709 | Kyocera Bipolar Hip System | KWY | Class II | Orthopedic |
| 2020-03-11 | K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | OQG | Class II | Orthopedic |
| 2020-02-04 | K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | Class II | Orthopedic |