FDA.reportPublic FDA data

510(k) K191927

Device
Hinged Laminoplasty System
Applicant
Life Spine, Inc.
510(k) number
K191927
Product code
NQW  
Decision
Substantially Equivalent (SESE)
Decision date
2019-09-20
Date received
2019-07-19
Regulation
888.3050
Classification name
Orthosis, Spine, Plate, Laminoplasty, Metal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Angela Batker
Address
13951 S Quality Dr. Huntley IL US 60142 60142

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NQW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.2024-10-28
K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC2024-10-16
K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC2023-10-10
K231232Curiteva Laminoplasty SystemCuriteva, Inc.2023-06-28
K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek2021-12-13
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

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases