Spectrum Spine Laminoplasty Plating System
FDA 510(k) K122822 · Spectrum Spine, LLC
510(k) numberK122822
Submission
- Device name
- Spectrum Spine Laminoplasty Plating System
- Applicant
- Spectrum Spine, LLC
Colorado Springs, CO, US - Received
- September 14, 2012
- Decision date
- February 7, 2013
- 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 |
| 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 |
More from Choicespine, LP
| 510(k) | Device | Decision |
|---|---|---|
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemODP · Traditional | 03/30/2026SE |
| K253377 | Expandable Titanium PLIF/TLIF SystemMAX · Special | 10/24/2025SE |
| K243074 | Spectrum Spine Lumbar Cage SystemMAX · Traditional | 04/04/2025SE |
| K240838 | Spectrum Spine Cervical Cage SystemODP · Traditional | 05/30/2024SE |
| K201024 | Expandable Titanium PLIF/TLIF SystemMAX · Traditional | 04/29/2021SE |
| K173518 | Spectrum Spine Expandable Cages (SSEC)MAX · Traditional | 03/07/2019SE |
| K132126 | Spectrum Spine Fenestrated Facet Screw SystemMRW · Traditional | 10/28/2013SE |
Questions and answers
When was Spectrum Spine Laminoplasty Plating System cleared by the FDA?
Spectrum Spine Laminoplasty Plating System (K122822) received a 510(k) decision of Substantially Equivalent on February 7, 2013, 146 days after the submission was received.
What is the product code of K122822?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.