Vy Spine VyLam Laminoplasty System
FDA 510(k) K242784 · Vy Spine, LLC
510(k) numberK242784
Submission
- Device name
- Vy Spine VyLam Laminoplasty System
- Applicant
- Vy Spine, LLC
Bountiful, UT, US - Received
- September 16, 2024
- Decision date
- October 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K232471 | Vy Spine VyLam Laminoplasty SystemNQW · Traditional | Vy Spine, LLC | 10/10/2023SE |
| K231232 | Curiteva Laminoplasty SystemNQW · Traditional | Curiteva, Inc. | 06/28/2023SE |
| 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 |
|---|---|---|
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | 03/27/2026SE |
| K253432 | DiversiVy Facet Screw SystemMRW · Traditional | 03/19/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | 01/07/2026SE |
| K241783 | FortiVy OsteoVy Lumbar IBFMAX · Traditional | 03/18/2025SE |
| K233807 | LumiVy Lumbar IBF SystemMAX · Traditional | 09/24/2024SE |
| K231836 | ClariVy Cervical IBF SystemODP · Traditional | 10/30/2023SE |
| K231744 | VyLink Spinal Screw SystemNKB · Traditional | 10/13/2023SE |
| K232471 | Vy Spine VyLam Laminoplasty SystemNQW · Traditional | 10/10/2023SE |
| K232167 | VySpan PCT SystemNKG · Special | 09/27/2023SE |
| K230414 | ClariVy Cervical IBF SystemODP · Special | 05/12/2023SE |
Questions and answers
When was Vy Spine VyLam Laminoplasty System cleared by the FDA?
Vy Spine VyLam Laminoplasty System (K242784) received a 510(k) decision of Substantially Equivalent on October 16, 2024, 30 days after the submission was received.
What is the product code of K242784?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.