NQW — Orthosis, Spine, Plate, Laminoplasty, Metal Class II
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 |
|---|---|---|---|
| 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 |
| K113218 | pioneer surgical technology | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM | January 26, 2012 |