Product code NQW
- Device name
- Orthosis, Spine, Plate, Laminoplasty, Metal
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3050
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024-10-28 |
| K242784 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2024-10-16 |
| K232471 | Vy Spine™ VyLam™ Laminoplasty System | Vy Spine, LLC | 2023-10-10 |
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023-06-28 |
| K212428 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek | 2021-12-13 |
| K191927 | Hinged Laminoplasty System | Life Spine, Inc. | 2019-09-20 |
| K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | 2019-07-03 |
| K181717 | Life Spine Laminoplasty System | Life Spine, Inc. | 2018-10-12 |
| K173215 | Choice Spine Laminoplasty™ Fixation System | Choicespine, LP | 2018-01-19 |
| K171413 | HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System | Globus Medical, Inc. | 2017-07-14 |
| K160114 | Xspan Laminoplasty Fixation System | X-Spine Systems, Inc. | 2016-03-15 |
| K153735 | Release Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-01-21 |
| K150469 | Integra Laminoplasty System | Seaspine, Inc. | 2015-03-23 |
| K132740 | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM | Spinefrontier, Inc. | 2013-11-26 |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | Seaspine, Inc. | 2013-05-09 |
| K122822 | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | Spectrum Spine, LLC | 2013-02-07 |
| K121732 | CANOPY LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | 2012-10-31 |
| K121276 | NEURO VENTION LAMINPLASTY PLATING SYSTEM | Neurovention, LLC | 2012-08-29 |
| K113802 | ESCALATE LAMINOPLASTY SYSTEM | Stryker Spine | 2012-04-16 |
| K113218 | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM | Pioneer Surgical Technology, Inc. | 2012-01-26 |
| K103284 | LAMINOPLASY PLATING SYSTEM | Aesculap Implant Systems, Inc. | 2010-12-02 |
| K100805 | GALLERY LAMINOPLASTY FIXATION SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2010-07-20 |
| K091994 | MOUNTAINEER LAMINOPLASTY SYSTEM | Depuy Spine, Inc. | 2010-01-07 |
| K091623 | LAMINOPLASTY FIXATION SYSTEM | Nuvasive, Inc. | 2009-10-09 |
| K090354 | LAMINOPLASTY PLATING SYSTEM | Aesculap Implant System, Inc. | 2009-05-12 |
| K080664 | RELIEVE LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | 2008-07-25 |
| K050082 | CENTERPIECE PLATE FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2005-06-06 |
| K043338 | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM | Blackstone Medical, Inc. | 2005-02-18 |
| K032534 | SYNTHES AFS | Synthes Spine | 2004-04-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10705034159102 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159096 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159188 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159171 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159164 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159157 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159140 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159133 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159126 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034159119 | MOUNTAINEER | Medos International Sàrl | 2015-09-24 |
| 10705034779959 | NA | Synthes GmbH | 2015-09-14 |
| 10705034779942 | NA | Synthes GmbH | 2015-09-14 |
| 10705034779935 | NA | Synthes GmbH | 2015-09-14 |
| 10705034779928 | NA | Synthes GmbH | 2015-09-14 |
| 10705034779911 | NA | Synthes GmbH | 2015-09-14 |
| 10705034779904 | NA | Synthes GmbH | 2015-09-14 |
| 10705034779898 | NA | Synthes GmbH | 2015-09-14 |
| 10705034779881 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778891 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778884 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778877 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778860 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778853 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778846 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778839 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778822 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778815 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778808 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778792 | NA | Synthes GmbH | 2015-09-14 |
| 10705034778785 | NA | Synthes GmbH | 2015-09-14 |