Curiteva Laminoplasty System
FDA 510(k) K231232 · Curiteva, Inc.
510(k) numberK231232
Submission
- Device name
- Curiteva Laminoplasty System
- Applicant
- Curiteva, Inc.
Tanner, AL, US - Received
- April 28, 2023
- Decision date
- June 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQW – Orthosis, Spine, Plate, Laminoplasty, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Other 510(k)s with product code NQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252930 | AQUA Laminoplasty SystemsNQW · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
| K243137 | Curiteva Porous PEEK Laminoplasty SystemNQW · Special | Curiteva, Inc. | 10/28/2024SE |
| K242784 | Vy Spine VyLam Laminoplasty SystemNQW · Special | Vy Spine, LLC | 10/16/2024SE |
| K232471 | Vy Spine VyLam Laminoplasty SystemNQW · Traditional | Vy Spine, LLC | 10/10/2023SE |
| K212428 | Centerpiece Plate Fixation SystemNQW · Traditional | Medtronic Sofamor Danek | 12/13/2021SE |
| K191927 | Hinged Laminoplasty SystemNQW · Traditional | Life Spine, Inc. | 09/20/2019SE |
| K191169 | NuVasive® Camber Laminoplasty SystemNQW · Traditional | Nu Vasive, Incorporated | 07/03/2019SE |
| K181717 | Life Spine Laminoplasty SystemNQW · Traditional | Life Spine, Inc. | 10/12/2018SE |
| K173215 | Choice Spine Laminoplasty Fixation SystemNQW · Traditional | Choicespine, LP | 01/19/2018SE |
| K171413 | HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation SystemNQW · Traditional | Globus Medical, Inc. | 07/14/2017SE |
More from Globus Medical, 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 |
| K233360 | Curiteva Thoracolumbar Plate SystemKWQ · Traditional | 02/29/2024SE |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion SystemMAX · Traditional | 01/18/2024SE |
| 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 Laminoplasty System cleared by the FDA?
Curiteva Laminoplasty System (K231232) received a 510(k) decision of Substantially Equivalent on June 28, 2023, 61 days after the submission was received.
What is the product code of K231232?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.