FDA 510(k) Applications for Medical Device Product Code "NQW"
(Orthosis, Spine, Plate, Laminoplasty, Metal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K090354 | AESCULAP IMPLANT SYSTEM, INC. | LAMINOPLASTY PLATING SYSTEM | 05/12/2009 |
| K103284 | AESCULAP IMPLANT SYSTEMS, INC. | LAMINOPLASY PLATING SYSTEM | 12/02/2010 |
| K100805 | BIOMET SPINE (AKA EBI, LLC) | GALLERY LAMINOPLASTY FIXATION SYSTEM | 07/20/2010 |
| K043338 | BLACKSTONE MEDICAL, INC. | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM | 02/18/2005 |
| K173215 | Choice Spine, LP | Choice Spine LaminoplastyÖ Fixation System | 01/19/2018 |
| K231232 | Curiteva, Inc. | Curiteva Laminoplasty System | 06/28/2023 |
| K091994 | DEPUY SPINE, INC. | MOUNTAINEER LAMINOPLASTY SYSTEM | 01/07/2010 |
| K121732 | GLOBUS MEDICAL INC. | CANOPY LAMINOPLASTY FIXATION SYSTEM | 10/31/2012 |
| K171413 | Globus Medical Inc. | HAVENÖ Laminoplasty System, CANOPY« Laminoplasty Fixation System | 07/14/2017 |
| K080664 | GLOBUS MEDICAL, INC. | RELIEVE LAMINOPLASTY FIXATION SYSTEM | 07/25/2008 |
| K181717 | Life Spine Inc. | Life Spine Laminoplasty System | 10/12/2018 |
| K191927 | Life Spine, Inc. | Hinged Laminoplasty System | 09/20/2019 |
| K212428 | Medtronic Sofamor Danek | Centerpiece Plate Fixation System | 12/13/2021 |
| K050082 | MEDTRONIC SOFAMOR DANEK, INC. | CENTERPIECE PLATE FIXATION SYSTEM | 06/06/2005 |
| K121276 | NEUROVENTION LLC | NEURO VENTION LAMINPLASTY PLATING SYSTEM | 08/29/2012 |
| K091623 | NUVASIVE, INC. | LAMINOPLASTY FIXATION SYSTEM | 10/09/2009 |
| K191169 | NuVasive, Incorporated | NuVasive« Camber Laminoplasty System | 07/03/2019 |
| K113218 | PIONEER SURGICAL TECHNOLOGY, INC | PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM | 01/26/2012 |
| K153735 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) | Release Laminoplasty Fixation System | 01/21/2016 |
| K130830 | SEASPINE, INC. | INTEGRA LAMINOPLASTY SYSTEM | 05/09/2013 |
| K150469 | SEASPINE, INC. | Integra Laminoplasty System | 03/23/2015 |
| K122822 | SPECTRUM SPINE, LLC | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | 02/07/2013 |
| K132740 | SPINEFRONTIER, INC. | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM | 11/26/2013 |
| K113802 | STRYKER SPINE | ESCALATE LAMINOPLASTY SYSTEM | 04/16/2012 |
| K032534 | SYNTHES SPINE | SYNTHES AFS | 04/01/2004 |
| K160114 | X-SPINE SYSTEMS, INC. | Xspan Laminoplasty Fixation System | 03/15/2016 |
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