Centerpiece Plate Fixation System
FDA 510(k) K212428 · Medtronic Sofamor Danek
510(k) numberK212428
Submission
- Device name
- Centerpiece Plate Fixation System
- Applicant
- Medtronic Sofamor Danek
Memphis, TN, US - Received
- August 4, 2021
- Decision date
- December 13, 2021
- 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 |
| 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 |
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Questions and answers
When was Centerpiece Plate Fixation System cleared by the FDA?
Centerpiece Plate Fixation System (K212428) received a 510(k) decision of Substantially Equivalent on December 13, 2021, 131 days after the submission was received.
What is the product code of K212428?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.