Integra Laminoplasty System
FDA 510(k) K130830 · Seaspine, Inc.
510(k) numberK130830
Submission
- Device name
- Integra Laminoplasty System
- Applicant
- Seaspine, Inc.
Vista, CA, US - Received
- March 26, 2013
- Decision date
- May 9, 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 |
|---|---|---|
| K231654 | NorthStar OCT SystemNKG · Traditional | 08/03/2023SE |
| K212135 | Dry DBM- A PuttyMQV · Traditional | 10/04/2021SE |
| K150469 | Integra Laminoplasty SystemNQW · Special | 03/23/2015SE |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…MAX · Traditional | 12/18/2014SE |
| K133418 | Integra Expandable Interverebral Body Fusion Device (Ibd) SystemMAX · Traditional | 05/01/2014SE |
| K132859 | Integra Facet Fixation SystemMRW · Traditional | 11/18/2013SE |
| K121924 | Integra Interspinous Process SystemPEK · Traditional | 09/04/2013SE |
| K122571 | Malibu Spinal System with the Daytona Deformity SystemNKB · Special | 12/12/2012SE |
| K112206 | Cardiff Anterior Cervical Plate SystemKWQ · Special | 01/25/2012SE |
| K111671 | Seaspine Monopolar Probe SysyemETN · Traditional | 12/28/2011SE |
Questions and answers
When was Integra Laminoplasty System cleared by the FDA?
Integra Laminoplasty System (K130830) received a 510(k) decision of Substantially Equivalent on May 9, 2013, 44 days after the submission was received.
What is the product code of K130830?
The FDA product code is NQW – Orthosis, Spine, Plate, Laminoplasty, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.