NQW — Orthosis, Spine, Plate, Laminoplasty, Metal Class II
FDA product code NQW covers "Orthosis, Spine, Plate, Laminoplasty, Metal", a Class II medical device regulated under 21 CFR 888.3050. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NQW
- Device Class
- Class II
- Regulation Number
- 888.3050
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252930 | zhejiang decans medical devices co | AQUA Laminoplasty Systems | May 27, 2026 |
| K243137 | curiteva | Curiteva Porous PEEK Laminoplasty System | October 28, 2024 |
| K242784 | vy spine | Vy Spine VyLam Laminoplasty System | October 16, 2024 |
| K232471 | vy spine | Vy Spine VyLam Laminoplasty System | October 10, 2023 |
| K231232 | curiteva | Curiteva Laminoplasty System | June 28, 2023 |
| K212428 | medtronic sofamor danek | Centerpiece Plate Fixation System | December 13, 2021 |
| K191927 | life spine | Hinged Laminoplasty System | September 20, 2019 |
| K191169 | nu vasive, incorporated | NuVasive® Camber Laminoplasty System | July 3, 2019 |
| K181717 | life spine | Life Spine Laminoplasty System | October 12, 2018 |
| K173215 | choicespine | Choice Spine Laminoplasty Fixation System | January 19, 2018 |
| K171413 | globus medical | HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation System | July 14, 2017 |
| K160114 | x-spine systems | Xspan Laminoplasty Fixation System | March 15, 2016 |
| K153735 | pioneer surgical technology, inc. (dba rti surgical, inc.) | Release Laminoplasty Fixation System | January 21, 2016 |
| K150469 | seaspine | Integra Laminoplasty System | March 23, 2015 |
| K132740 | spinefrontier | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM | November 26, 2013 |
| K130830 | seaspine | INTEGRA LAMINOPLASTY SYSTEM | May 9, 2013 |
| K122822 | spectrum spine | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | February 7, 2013 |
| K121732 | globus medical | CANOPY LAMINOPLASTY FIXATION SYSTEM | October 31, 2012 |
| K121276 | neurovention | NEURO VENTION LAMINPLASTY PLATING SYSTEM | August 29, 2012 |
| K113802 | stryker spine | ESCALATE LAMINOPLASTY SYSTEM | April 16, 2012 |