Atlas FDA

NQW

30 FDA 510(k) clearances · Product code

90 daysmedian time to decision
189 days90th percentile
30clearances measured

FDA profile

Official device name
Orthosis, Spine, Plate, Laminoplasty, Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3050
Medical specialty
Orthopedic
Flags
Implant
FDA definition
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Adverse events (MAUDE)
2013: 49 · 2015: 11 · 2017: 19 · 2022: 16 · 2025: 33 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AQUA Laminoplasty Systems (K252930)ZheJiang Decans Medical Devices Co., Ltd.2026-05-27
Curiteva Porous PEEK Laminoplasty System (K243137)Curiteva, Inc.2024-10-28
Vy Spine™ VyLam™ Laminoplasty System (K242784)Vy Spine, LLC2024-10-16
Vy Spine™ VyLam™ Laminoplasty System (K232471)Vy Spine, LLC2023-10-10
Curiteva Laminoplasty System (K231232)Curiteva, Inc.2023-06-28
Centerpiece Plate Fixation System (K212428)Medtronic Sofamor Danek2021-12-13
Hinged Laminoplasty System (K191927)Life Spine, Inc.2019-09-20
NuVasive® Camber Laminoplasty System (K191169)Nu Vasive, Incorporated2019-07-03
Life Spine Laminoplasty System (K181717)Life Spine, Inc.2018-10-12
Choice Spine Laminoplasty™ Fixation System (K173215)Choicespine, LP2018-01-19
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (K171413)Globus Medical, Inc.2017-07-14
Xspan Laminoplasty Fixation System (K160114)X-Spine Systems, Inc.2016-03-15
Release Laminoplasty Fixation System (K153735)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2016-01-21
Integra Laminoplasty System (K150469)Seaspine, Inc.2015-03-23
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM (K132740)Spinefrontier, Inc.2013-11-26
INTEGRA LAMINOPLASTY SYSTEM (K130830)Seaspine, Inc.2013-05-09
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM (K122822)Spectrum Spine, LLC2013-02-07
CANOPY LAMINOPLASTY FIXATION SYSTEM (K121732)Globus Medical, Inc.2012-10-31
NEURO VENTION LAMINPLASTY PLATING SYSTEM (K121276)Neurovention, LLC2012-08-29
ESCALATE LAMINOPLASTY SYSTEM (K113802)Stryker Spine2012-04-16
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM (K113218)Pioneer Surgical Technology, Inc.2012-01-26
LAMINOPLASY PLATING SYSTEM (K103284)Aesculap Implant Systems, Inc.2010-12-02
GALLERY LAMINOPLASTY FIXATION SYSTEM (K100805)Biomet Spine (Aka Ebi, LLC)2010-07-20
MOUNTAINEER LAMINOPLASTY SYSTEM (K091994)Depuy Spine, Inc.2010-01-07
LAMINOPLASTY FIXATION SYSTEM (K091623)Nuvasive, Inc.2009-10-09
LAMINOPLASTY PLATING SYSTEM (K090354)Aesculap Implant System, Inc.2009-05-12
RELIEVE LAMINOPLASTY FIXATION SYSTEM (K080664)Globus Medical, Inc.2008-07-25
CENTERPIECE PLATE FIXATION SYSTEM (K050082)Medtronic Sofamor Danek, Inc.2005-06-06
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM (K043338)Blackstone Medical, Inc.2005-02-18
SYNTHES AFS (K032534)Synthes Spine2004-04-01

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