FDA.report

510(k) K243137

Device
Curiteva Porous PEEK Laminoplasty System
Applicant
Curiteva, Inc.
510(k) number
K243137
Product code
NQW
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-28
Date received
2024-09-30
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

Related Records

Applicant Contact

Contact
Eric Linder
Address
25127 Will Mccomb Dr. Tanner AL US 35671 35671

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code NQW

510(k)DeviceApplicantDecision date
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
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