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510(k) K153442

Device
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments For Use With The STEALTHSTATION System, Medtronic Reusable Instruments For Use With The IPC POWEREASE System, Medtronic Navigated Reusable Instruments For Use With The STEALTHS
Applicant
Medtronic Sofamor Danek USA, Inc.
510(k) number
K153442
Product code
NKB  
Decision
Substantially Equivalent (SESE)
Decision date
2016-02-18
Date received
2015-11-27
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
Lila Joe
Address
1800 Pyramid Pl. Memphis TN US 38132 38132

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
K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi2026-09-17
K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical2026-09-14
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

Legacy Summary#

summary

FDA Review#

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