FDA Product Code
FDA Product Code NQW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3050
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252930 | AQUA Laminoplasty Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 | Traditional | PDF ↗ |
| K243137 | Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. | 2024-10-28 | Special | PDF ↗ |
| K242784 | Vy Spine VyLam Laminoplasty System | Vy Spine, LLC | 2024-10-16 | Special | PDF ↗ |
| K232471 | Vy Spine VyLam Laminoplasty System | Vy Spine, LLC | 2023-10-10 | Traditional | PDF ↗ |
| K231232 | Curiteva Laminoplasty System | Curiteva, Inc. | 2023-06-28 | Traditional | PDF ↗ |
| K212428 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek | 2021-12-13 | Traditional | PDF ↗ |
| K191927 | Hinged Laminoplasty System | Life Spine, Inc. | 2019-09-20 | Traditional | PDF ↗ |
| K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | 2019-07-03 | Traditional | PDF ↗ |
| K181717 | Life Spine Laminoplasty System | Life Spine, Inc. | 2018-10-12 | Traditional | PDF ↗ |
| K173215 | Choice Spine Laminoplasty Fixation System | Choicespine, LP | 2018-01-19 | Traditional | PDF ↗ |
| K171413 | HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation System | Globus Medical, Inc. | 2017-07-14 | Traditional | PDF ↗ |
| K160114 | Xspan Laminoplasty Fixation System | X-Spine Systems, Inc. | 2016-03-15 | Traditional | PDF ↗ |
| K153735 | Release Laminoplasty Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-01-21 | Special | PDF ↗ |
| K150469 | Integra Laminoplasty System | Seaspine, Inc. | 2015-03-23 | Special | PDF ↗ |
| K132740 | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM | Spinefrontier, Inc. | 2013-11-26 | Traditional | PDF ↗ |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | Seaspine, Inc. | 2013-05-09 | Traditional | PDF ↗ |
| K122822 | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | Spectrum Spine, LLC | 2013-02-07 | Traditional | PDF ↗ |
| K121732 | CANOPY LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | 2012-10-31 | Special | PDF ↗ |
| K121276 | NEURO VENTION LAMINPLASTY PLATING SYSTEM | Neurovention, LLC | 2012-08-29 | Traditional | PDF ↗ |
| K113802 | ESCALATE LAMINOPLASTY SYSTEM | Stryker Spine | 2012-04-16 | Traditional | PDF ↗ |
| K113218 | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM | Pioneer Surgical Technology, Inc. | 2012-01-26 | Traditional | PDF ↗ |
| K103284 | LAMINOPLASY PLATING SYSTEM | Aesculap Implant Systems, Inc. | 2010-12-02 | Special | PDF ↗ |
| K100805 | GALLERY LAMINOPLASTY FIXATION SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2010-07-20 | Traditional | PDF ↗ |
| K091994 | MOUNTAINEER LAMINOPLASTY SYSTEM | Depuy Spine, Inc. | 2010-01-07 | Traditional | PDF ↗ |
| K091623 | LAMINOPLASTY FIXATION SYSTEM | Nuvasive, Inc. | 2009-10-09 | Traditional | PDF ↗ |
| K090354 | LAMINOPLASTY PLATING SYSTEM | Aesculap Implant System, Inc. | 2009-05-12 | Traditional | PDF ↗ |
| K080664 | RELIEVE LAMINOPLASTY FIXATION SYSTEM | Globus Medical, Inc. | 2008-07-25 | Traditional | PDF ↗ |
| K050082 | CENTERPIECE PLATE FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2005-06-06 | Traditional | PDF ↗ |
| K043338 | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM | Blackstone Medical, Inc. | 2005-02-18 | Traditional | PDF ↗ |
| K032534 | SYNTHES AFS | Synthes Spine | 2004-04-01 | Traditional | PDF ↗ |
Product code NQW · Class II · Orthopedic. Data: openFDA.