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Panels › Orthopedic › Product code NKB · Class 2

Thoracolumbosacral Pedicle Screw System

Regulation 888.3070

33510(k)s in 12 months (914 all time)
4recalls in 12 months (182 all time)
177recalls that name a 510(k)
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Top companies in NKB

Company510(k)sRecalls
Medtronic Sofamor Danek982
Depuy Spine, Inc.3010
Nuvasive, Inc.931
Spinal Elements, Inc.1122
Stryker Spine225
Alphatec Spine, Inc.205
Zimmer Biomet, Inc.025
Globus Medical, Inc.240
Life Spine220
K2m200
Decided510(k)Device and applicantCode
Oct 2, 2026K261217AnyPlus II Spinal Fixation System
GS Medical Co., Ltd., KR
NKB
Oct 1, 2026K263062NOVIX Pedicle Screw System
Tdm Co., Ltd., KR
NKB
Sep 30, 2026K263172SAS MIS Pelvic Incidence Rods
Spinal Alignment Solutions, Inc.
NKB
Sep 30, 2026K262712Duet™ Spinal Fixation System
Duet Spine Holdings, LLC
NKB
Sep 27, 2026K252139Kentrospine Viktr-MIS® Pedicle screw system
Rivarp Medical Pvt., Ltd., IN
NKB
Sep 23, 2026K262067iFuse Granite Onyx™ Implant System
SI-BONE, Inc.
NKB
Sep 17, 2026K262091FRAXION Spinal Fixation System
Ortler Global Tibbi Gerecler Anonim Sirketi, TR
NKB
Sep 14, 2026K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTI
Xenix Medical
NKB
Sep 4, 2026K262828KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O, FR
NKB
Jul 24, 2026K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
MANTIZ Co., Ltd., KR
NKB
Jul 24, 2026K253943Tiger 2 System
Zavation Medical Products, LLC
NKB
Jul 14, 2026K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
Alphatec Spine, Inc.
NKB
Jul 1, 2026K253802KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O, FR
NKB
Jun 17, 2026K253045“Socko” Vimax Spinal Fixation System
Socko Medical Co., Ltd., TW
NKB
Jun 9, 2026K251251ChanPin Pedicle Screw Spinal System
Chanpin Medtak Co., Ltd., TW
NKB
May 15, 2026K260989Varion Thoracolumbar Fixation System
Kyocera Medical Technologies Inc. (KMTI)
NKB
May 7, 2026K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reli
Globus Medical, Inc.
NKB
May 5, 2026K261130AccelFix Spinal Fixation System
L&K BIOMED Co., Ltd., KR
NKB
May 1, 2026K253966PERLA® TL Posterior Thoraco-lumbar Fixation System
Spineart SA, CH
NKB
Apr 29, 2026K252542LEO Spinal System
ZheJiang Decans Medical Devices Co., Ltd., CN
NKB
Apr 28, 2026K253940M.U.S.T. Pedicle Screw System - Extension
Medacta International S.A., CH
NKB
Apr 21, 2026K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Apr 16, 2026K254274ARx® SAI Implant System
Life Spine, Inc.
NKB
Apr 3, 2026K260786KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O, FR
NKB
Feb 24, 2026K254247OSTEOMNI SPINAL FIXATION SYSTEM
Osteomni, Inc.
NKB
Feb 23, 2026K253169Duet™ Spinal Fixation System
Box Spine, LLC
NKB
Feb 10, 2026K253545Vulcan Spinal System
K2m, Inc.
NKB
Jan 13, 2026K252461Swedge™ Pedicle Screw Fixation System Bezier Rod
Spinal Resources, Inc.
NKB
Jan 7, 2026K253990KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O, FR
NKB
Jan 7, 2026K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
Medtronic Sofamor Danek USA, Inc.
NKB
Dec 17, 2025K253721KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O, FR
NKB
Dec 17, 2025K253093Vital™ Spinal Fixation System
Highridge Medical, LLC
NKB
Nov 18, 2025K252729Universal Spinal System
Double Medical Technology, Inc., CN
NKB
Oct 24, 2025K253335CD Horizon™ Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Oct 24, 2025K252730Fule Spinal Fixation System
Beijing Fule Science & Technology Development Co., Ltd., CN
NKB
Oct 21, 2025K253249TriALTIS™ Spine System
Medos International SARL, CH
NKB
Oct 21, 2025K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
Astura Medical
NKB
Oct 20, 2025K242827A8 INTEGR8™ Porous Pedicle Screws
Allumin8, Inc.
NKB
Oct 14, 2025K253331PressON Spinal Fixation System
Nexus Spine
NKB
Aug 28, 2025K252437JAZZ Spinal System
Implanet, FR
NKB
Jul 8, 2025K251804KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O, FR
NKB
Jul 1, 2025K251719Momentum® Posterior Spinal Fixation System
Ulrich Medical USA, Inc.
NKB
Jun 18, 2025K250908Virata Spinal Fixation System
SeaSpine Orthopedics Corporation
NKB
Jun 12, 2025K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
Ht Medical D.B.A. Xenix Medical
NKB
Jun 6, 2025K251131Annex® 2 Adjacent Level System
Spine Wave, Inc.
NKB
May 8, 2025K250582COLONNADE Posterior Screw Fixation System
CG Bio Co., Ltd., KR
NKB
Apr 28, 2025K241663Eminent Spine 3D Titanium Pedicle Screw System
Eminent Spine
NKB
Mar 27, 2025K250092HC Biologics Osteopoint Spinal Fixation System
HC Biologics, LLC
NKB
Feb 27, 2025K242900VADER® Pedicle System and VADER®one Pedicle System
Icotec AG, CH
NKB
Feb 21, 2025K243916Primus Spinal Fixation System
Spinal Elements, Inc.
NKB

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