FDA.reportPublic FDA data

510(k) K190418

Device
NuVasive® VersaTie® System
Applicant
NuVasive, Incorporated
510(k) number
K190418
Product code
OWI  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-21
Date received
2019-02-21
Regulation
888.3010
Classification name
Bone Fixation Cerclage, Sublaminar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joseph De La Rosa
Address
7475 Lusk Blvd. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OWI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261374LigaPASS™ SystemMedicrea International S.A.S2026-05-27
K253615Invictus Bands SystemAlphatec Spine, Inc.2026-03-25
K222097OLYMPIC Deformity Band SystemAstura Medical2023-05-04
K230565HILINE™ Fixation SystemGlobus Medical, Inc.2023-04-20
K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA2022-05-24
K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.2021-05-27
K201240Mariner Cap SystemSeaSpine Orthopedics Corporation2020-08-05
K200281The Gecko Spinal SystemOrtho Development Corporation2020-03-31
K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.2020-03-16
K191217JAZZ PFImplanet, S.A.2019-08-02
K190289Karma® Fixation SystemSpinal Elements, Inc.2019-04-03
K180728Spinal Elements Cerclage SystemSpinal Elements, Inc.2018-09-06
K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas2018-08-29
K172206NAJA™ Ligament Correction SystemCousin Biotech Sas2018-04-10
K173506LigaPASSMedicrea International SA2018-04-03