Curiteva Thoracolumbar Plate System
FDA 510(k) K233360 · Curiteva, Inc.
510(k) numberK233360
Submission
- Device name
- Curiteva Thoracolumbar Plate System
- Applicant
- Curiteva, Inc.
Tanner, AL, US - Received
- September 29, 2023
- Decision date
- February 29, 2024
- 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 |
|---|---|---|
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…ODP · Traditional | 01/16/2026SE |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion SystemODP · Special | 01/15/2026SE |
| K250845 | Curiteva Porous PEEK Standalone ALIF SystemOVD · Traditional | 06/18/2025SE |
| K243137 | Curiteva Porous PEEK Laminoplasty SystemNQW · Special | 10/28/2024SE |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion SystemMAX · Traditional | 01/18/2024SE |
| K231232 | Curiteva Laminoplasty SystemNQW · Traditional | 06/28/2023SE |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion SystemODP · Traditional | 02/13/2023SE |
| K223200 | Curiteva Navigation SystemOLO · Traditional | 01/06/2023SE |
| K210402 | Curiteva Sacroiliac Joint Fusion SystemOUR · Traditional | 09/09/2021SE |
| K191810 | Curiteva Pedicle Screw SystemNKB · Traditional | 08/28/2019SE |
Questions and answers
When was Curiteva Thoracolumbar Plate System cleared by the FDA?
Curiteva Thoracolumbar Plate System (K233360) received a 510(k) decision of Substantially Equivalent on February 29, 2024, 153 days after the submission was received.
What is the product code of K233360?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.