FDA.reportPublic FDA data

510(k) K251154

Device
RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
Applicant
Ht Medical D.B.A. Xenix Medical
510(k) number
K251154
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-12
Date received
2025-04-14
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tyler Holschlag
Address
111 W. Jefferson St. Suite 100 Orlando FL US 32801 32801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NKB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-09-04
K253943Tiger 2 SystemZavation Medical Products, LLC2026-07-24
K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.2026-07-24
K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.2026-07-14
K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-07-01
K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.2026-06-17
K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.2026-06-09
K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)2026-05-15
K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ SystemGlobus Medical, Inc.2026-05-07
K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.2026-05-05
K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA2026-05-01
K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-29
K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2026-04-28
K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2026-04-21
K254274ARx® SAI Implant SystemLife Spine, Inc.2026-04-16