FDA.report

510(k) K242784

Device
Vy Spine™ VyLam™ Laminoplasty System
Applicant
Vy Spine, LLC
510(k) number
K242784
Product code
NQW
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-16
Date received
2024-09-16
Regulation
888.3050
Classification name
Orthosis, Spine, Plate, Laminoplasty, Metal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jordan Hendrickson
Address
545 W 500 S. Suite 100 Bountiful UT US 84011 84011

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code NQW

510(k)DeviceApplicantDecision date
K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.2024-10-28
K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC2023-10-10
K231232Curiteva Laminoplasty SystemCuriteva, Inc.2023-06-28
K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek2021-12-13
K191927Hinged Laminoplasty SystemLife Spine, Inc.2019-09-20
K191169NuVasive® Camber Laminoplasty SystemNu Vasive, Incorporated2019-07-03
K181717Life Spine Laminoplasty SystemLife Spine, Inc.2018-10-12
K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP2018-01-19
K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.2017-07-14
K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.2016-03-15
K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2016-01-21
K150469Integra Laminoplasty SystemSeaspine, Inc.2015-03-23
K132740SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEMSpinefrontier, Inc.2013-11-26
K130830INTEGRA LAMINOPLASTY SYSTEMSeaspine, Inc.2013-05-09
K122822SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEMSpectrum Spine, LLC2013-02-07