Salt Lake City, UT, US · 12 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 3 | 2025-07-23 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 3 | 2023-10-17 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 2 | 2025-03-24 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2025-09-25 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2024-05-20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2020-07-15 |
| FST | Light, Surgical, Fiberoptic | Class II | General, Plastic Surgery | 1 | 2020-06-30 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-08-14 | Class II | Ongoing | Z-3163-2024 | TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fu… | — | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. |
| 2020-04-07 | Class II | Terminated | Z-2062-2020 | Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical… | — | Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-09-25 | K250076 | Endeavor Stand-Alone Cervical IBF System | OVE | Class II | Orthopedic |
| 2025-07-23 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | OLO | Class II | Neurology |
| 2025-03-24 | K250603 | AxTiHA® Stand-Alone ALIF System | OVD | Class II | Orthopedic |
| 2025-03-24 | K250182 | Innovasis Navigation Instruments | OLO | Class II | Neurology |
| 2024-05-20 | K241276 | Vector Pedicle Screw System | NKB | Class II | Orthopedic |
| 2023-10-17 | K231899 | HAtetracell-C Titanium Cervical IBF System | ODP | Class II | Orthopedic |
| 2023-05-02 | K223511 | Excella Navigation Instruments | OLO | Class II | Neurology |
| 2022-12-12 | K223510 | Matrix HA Fusion Porous Cervical IBF System | ODP | Class II | Orthopedic |
| 2022-08-26 | K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | ODP | Class II | Orthopedic |
| 2021-10-15 | K212967 | AxTiHA Stand-Alone ALIF System | OVD | Class II | Orthopedic |
| 2020-07-15 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | MAX | Class II | Orthopedic |
| 2020-06-30 | K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | FST | Class II | General, Plastic Surgery |