Jiaxing, CN · 11 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | 2 | 2026-05-27 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 2 | 2026-04-20 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 1 | 2026-06-16 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | 1 | 2026-06-02 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Class II | Orthopedic | 1 | 2026-05-27 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 1 | 2026-05-14 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2026-04-29 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2024-11-04 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2024-10-08 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-16 | K253046 | HERA Interlocking Intramedullary Nailing System | HSB | Class II | Orthopedic |
| 2026-06-02 | K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | NKG | Class II | Orthopedic |
| 2026-05-27 | K253130 | Dione PEEK Screw System | MBI | Class II | Orthopedic |
| 2026-05-27 | K252930 | AQUA Laminoplasty Systems | NQW | Class II | Orthopedic |
| 2026-05-14 | K252776 | ARIES Anterior Cervical Plate Systems | KWQ | Class II | Orthopedic |
| 2026-04-29 | K252542 | LEO Spinal System | NKB | Class II | Orthopedic |
| 2026-04-20 | K253213 | SAGI Cervical Cage System | OVE | Class II | Orthopedic |
| 2026-04-15 | K252774 | Uni-C Cervical Cage System | OVE | Class II | Orthopedic |
| 2025-01-31 | K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | MBI | Class II | Orthopedic |
| 2024-11-04 | K242195 | Gemini Cervical Fusion Cage System | ODP | Class II | Orthopedic |
| 2024-10-08 | K242267 | Gemini Medical Cage System | MAX | Class II | Orthopedic |