ClearanceBrief
Panels › Orthopedic › Product code NQW · Class 2

Orthosis, Spine, Plate, Laminoplasty, Metal

Regulation 888.3050

1510(k)s in 12 months (30 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in NQW

Company510(k)sRecalls
Globus Medical, Inc.30
Curiteva, Inc.20
Life Spine, Inc.20
Medtronic Sofamor Danek20
Seaspine, Inc.20
Vy Spine, LLC20
Aesculap Implant System, Inc.10
Aesculap Implant Systems, Inc.10
Biomet Spine (Aka Ebi, LLC)10
Blackstone Medical, Inc.10
Decided510(k)Device and applicantCode
May 27, 2026K252930AQUA Laminoplasty Systems
ZheJiang Decans Medical Devices Co., Ltd., CN
NQW
Oct 28, 2024K243137Curiteva Porous PEEK Laminoplasty System
Curiteva, Inc.
NQW
Oct 16, 2024K242784Vy Spine™ VyLam™ Laminoplasty System
Vy Spine, LLC
NQW
Oct 10, 2023K232471Vy Spine™ VyLam™ Laminoplasty System
Vy Spine, LLC
NQW
Jun 28, 2023K231232Curiteva Laminoplasty System
Curiteva, Inc.
NQW
Dec 13, 2021K212428Centerpiece Plate Fixation System
Medtronic Sofamor Danek
NQW
Sep 20, 2019K191927Hinged Laminoplasty System
Life Spine, Inc.
NQW
Jul 3, 2019K191169NuVasive® Camber Laminoplasty System
Nu Vasive, Incorporated
NQW
Oct 12, 2018K181717Life Spine Laminoplasty System
Life Spine, Inc.
NQW
Jan 19, 2018K173215Choice Spine Laminoplasty™ Fixation System
Choicespine, LP
NQW
Jul 14, 2017K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
Globus Medical, Inc.
NQW
Mar 15, 2016K160114Xspan Laminoplasty Fixation System
X-Spine Systems, Inc.
NQW
Jan 21, 2016K153735Release Laminoplasty Fixation System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
NQW
Mar 23, 2015K150469Integra Laminoplasty System
Seaspine, Inc.
NQW
Nov 26, 2013K132740SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
Spinefrontier, Inc.
NQW
May 9, 2013K130830INTEGRA LAMINOPLASTY SYSTEM
Seaspine, Inc.
NQW
Feb 7, 2013K122822SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
Spectrum Spine, LLC
NQW
Oct 31, 2012K121732CANOPY LAMINOPLASTY FIXATION SYSTEM
Globus Medical, Inc.
NQW
Aug 29, 2012K121276NEURO VENTION LAMINPLASTY PLATING SYSTEM
Neurovention, LLC
NQW
Apr 16, 2012K113802ESCALATE LAMINOPLASTY SYSTEM
Stryker Spine
NQW
Jan 26, 2012K113218PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
Pioneer Surgical Technology, Inc.
NQW
Dec 2, 2010K103284LAMINOPLASY PLATING SYSTEM
Aesculap Implant Systems, Inc.
NQW
Jul 20, 2010K100805GALLERY LAMINOPLASTY FIXATION SYSTEM
Biomet Spine (Aka Ebi, LLC)
NQW
Jan 7, 2010K091994MOUNTAINEER LAMINOPLASTY SYSTEM
Depuy Spine, Inc.
NQW
Oct 9, 2009K091623LAMINOPLASTY FIXATION SYSTEM
Nuvasive, Inc.
NQW
May 12, 2009K090354LAMINOPLASTY PLATING SYSTEM
Aesculap Implant System, Inc.
NQW
Jul 25, 2008K080664RELIEVE LAMINOPLASTY FIXATION SYSTEM
Globus Medical, Inc.
NQW
Jun 6, 2005K050082CENTERPIECE PLATE FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
NQW
Feb 18, 2005K043338BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
Blackstone Medical, Inc.
NQW
Apr 1, 2004K032534SYNTHES AFS
Synthes Spine
NQW

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