NuVasive® Camber Laminoplasty System
FDA 510(k) K191169 · Nu Vasive, Incorporated
510(k) numberK191169
Submission
- Device name
- NuVasive® Camber Laminoplasty System
- Applicant
- Nu Vasive, Incorporated
San Diego, CA, US - Received
- May 1, 2019
- Decision date
- July 3, 2019
- 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 |
| 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 |
| 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 |
|---|---|---|
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…ODP · Special | 07/11/2023SE |
| K230894 | NuVasive Modulus ALIF SystemOVD · Traditional | 06/16/2023SE |
| K230989 | Rod Registration FrameOLO · Special | 05/05/2023SE |
| K223181 | NuVasive Reline SystemNKB · Traditional | 01/11/2023SE |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD · Traditional | 10/21/2022SE |
| K221388 | NuVasive Reline Cervical SystemNKG · Traditional | 09/09/2022SE |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional | 06/21/2022SE |
| K213654 | NuVasive Reline Cervical SystemNKG · Traditional | 02/23/2022SE |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional | 12/23/2021SE |
| K212446 | NuVasive Anterior Cervical Plate SystemsKWQ · Traditional | 11/03/2021SE |
Questions and answers
When was NuVasive® Camber Laminoplasty System cleared by the FDA?
NuVasive® Camber Laminoplasty System (K191169) received a 510(k) decision of Substantially Equivalent on July 3, 2019, 63 days after the submission was received.
What is the product code of K191169?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.