Xspan Laminoplasty Fixation System
FDA 510(k) K160114 · X-Spine Systems, Inc.
510(k) numberK160114
Submission
- Device name
- Xspan Laminoplasty Fixation System
- Applicant
- X-Spine Systems, Inc.
Miamisburg, OH, US - Received
- January 19, 2016
- Decision date
- March 15, 2016
- 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 |
|---|---|---|
| K173832 | InTice-C Porous Ti Cervical Interbody SystemODP · Traditional | 05/17/2018SE |
| K180153 | X-spine Cortical Bone Screw SystemNKB · Traditional | 03/15/2018SE |
| K170119 | Calix Lumbar Spinal Implant SystemMAX · Traditional | 09/29/2017SE |
| K171567 | IRIX-A Lumbar Integrated Fusion SystemOVD · Traditional | 08/28/2017SE |
| K171075 | Calix-C Cervical Interbody SpacerODP · Traditional | 08/01/2017SE |
| K170224 | Spider Cervical Plating SystemKWQ · Traditional | 07/06/2017SE |
| K170530 | Butrex Lumbar Buttress Plating SystemKWQ · Special | 03/22/2017SE |
| K160959 | Xsert Lumbar Expandable Interbody SystemMAX · Traditional | 11/17/2016SE |
| K162944 | Irix-C Cervical Integrated Fusion SystemOVE · Traditional | 11/07/2016SE |
| K160428 | Certex Spinal Fixation SystemNKG · Traditional | 05/05/2016SE |
Questions and answers
When was Xspan Laminoplasty Fixation System cleared by the FDA?
Xspan Laminoplasty Fixation System (K160114) received a 510(k) decision of Substantially Equivalent on March 15, 2016, 56 days after the submission was received.
What is the product code of K160114?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.