NQW · Orthosis, Spine, Plate, Laminoplasty, Metal
Orthopedic · 21 CFR 888.3050 · Class 2
Overview
| Product Code | NQW |
|---|---|
| Device Name | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
Classification Rationale
Class II.
Cleared Devices (29)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | Oct 28, 2024 | SESE |
| K242784 | Vy Spine VyLam Laminoplasty System | Vy Spine, LLC | Oct 16, 2024 | SESE |
| K232471 | Vy Spine VyLam Laminoplasty System | Vy Spine, LLC | Oct 10, 2023 | SESE |
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | Jun 28, 2023 | SESE |
| K212428 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek | Dec 13, 2021 | SESE |
| K191927 | Hinged Laminoplasty System | Life Spine, Inc. | Sep 20, 2019 | SESE |
| K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | Jul 3, 2019 | SESE |
| K181717 | Life Spine Laminoplasty System | Life Spine, Inc. | Oct 12, 2018 | SESE |
| K173215 | Choice Spine Laminoplasty Fixation System | Choicespine, LP | Jan 19, 2018 | SESE |
| K171413 | HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation System | Globus Medical, Inc. | Jul 14, 2017 | SESE |
| K160114 | Xspan Laminoplasty Fixation System | X-Spine Systems, Inc. | Mar 15, 2016 | SESE |
| K153735 | Release Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Jan 21, 2016 | SESE |
| K150469 | Integra Laminoplasty System | Seaspine, Inc. | Mar 23, 2015 | SESE |
| K132740 | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM | Spinefrontier, Inc. | Nov 26, 2013 | SESE |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | Seaspine, Inc. | May 9, 2013 | SESE |
| K122822 | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | Spectrum Spine, LLC | Feb 7, 2013 | SESE |
| K121732 | CANOPY LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | Oct 31, 2012 | SESE |
| K121276 | NEURO VENTION LAMINPLASTY PLATING SYSTEM | Neurovention, LLC | Aug 29, 2012 | SESE |
| K113802 | ESCALATE LAMINOPLASTY SYSTEM | Stryker Spine | Apr 16, 2012 | SESE |
| K113218 | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM | Pioneer Surgical Technology, Inc. | Jan 26, 2012 | SESE |
| K103284 | LAMINOPLASY PLATING SYSTEM | Aesculap Implant Systems, Inc. | Dec 2, 2010 | SESE |
| K100805 | GALLERY LAMINOPLASTY FIXATION SYSTEM | Biomet Spine (Aka Ebi, LLC) | Jul 20, 2010 | SESE |
| K091994 | MOUNTAINEER LAMINOPLASTY SYSTEM | Depuy Spine, Inc. | Jan 7, 2010 | SESE |
| K091623 | LAMINOPLASTY FIXATION SYSTEM | Nuvasive, Inc. | Oct 9, 2009 | SESE |
| K090354 | LAMINOPLASTY PLATING SYSTEM | Aesculap Implant System, Inc. | May 12, 2009 | SESE |
| K080664 | RELIEVE LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | Jul 25, 2008 | SESE |
| K050082 | CENTERPIECE PLATE FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | Jun 6, 2005 | SESE |
| K043338 | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM | Blackstone Medical, Inc. | Feb 18, 2005 | SESE |
| K032534 | SYNTHES AFS | Synthes Spine | Apr 1, 2004 | SESE |
Top Applicants
- Globus Medical, Inc. — 3 clearances
- Vy Spine, LLC — 2 clearances
- Seaspine, Inc. — 2 clearances
- Life Spine, Inc. — 2 clearances
- Curiteva, Inc. — 2 clearances
