Oryx Cervical Plate System
FDA 510(k) K192049 · Innovasis, Inc.
510(k) numberK192049
Submission
- Device name
- Oryx Cervical Plate System
- Applicant
- Innovasis, Inc.
Salt Lake City, UT, US - Received
- July 31, 2019
- Decision date
- November 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250076 | Endeavor Stand-Alone Cervical IBF SystemOVE · Traditional | 09/25/2025SE |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…OLO · Traditional | 07/23/2025SE |
| K250603 | AxTiHA® Stand-Alone ALIF SystemOVD · Special | 03/24/2025SE |
| K250182 | Innovasis Navigation InstrumentsOLO · Traditional | 03/24/2025SE |
| K241276 | Vector Pedicle Screw SystemNKB · Traditional | 05/20/2024SE |
| K231899 | HAtetracell-C Titanium Cervical IBF SystemODP · Traditional | 10/17/2023SE |
| K223511 | Excella Navigation InstrumentsOLO · Traditional | 05/02/2023SE |
| K223510 | Matrix HA Fusion Porous Cervical IBF SystemODP · Special | 12/12/2022SE |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemODP · Traditional | 08/26/2022SE |
| K212967 | AxTiHA Stand-Alone ALIF SystemOVD · Special | 10/15/2021SE |
Questions and answers
When was Oryx Cervical Plate System cleared by the FDA?
Oryx Cervical Plate System (K192049) received a 510(k) decision of Substantially Equivalent on November 8, 2019, 100 days after the submission was received.
What is the product code of K192049?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.