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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
Feb 3, 2025K243908Tiger 2 System
Zavation Medical Products, LLC
NKB
Jan 17, 2025K243249TriALTIS™ Spine System
Medos International SARL, CH
NKB
Jan 15, 2025K243946EffortMed Spinal Fixation System
Effortmed, LLC
NKB
Jan 7, 2025K243259MASADA Modular Spinal Fixation System
Astura Medical
NKB
Dec 23, 2024K243693NEO Pedicle Screw System™
Neo Medical SA, CH
NKB
Dec 17, 2024K242297Reform Pedicle Screw System
Precision Spine, Inc.
NKB
Dec 13, 2024K243281LOCK-IN Spinal Fixation System
Lock-In USA Corp
NKB
Nov 26, 2024K2316554CIS® Chiron Spinal Fixation System
Solco Biomedical Co., Ltd., KR
NKB
Nov 13, 2024K242764MediRod Pedicle Screw System
Cmf Medicon Surgical, Inc.
NKB
Nov 8, 2024K243004Xpine Spinal Fixation System
Jeil Medical Corporation, KR
NKB
Nov 5, 2024K243106CarboClear® Hybrid Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Oct 28, 2024K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
Spinal Alignment Solutions, Inc.
NKB
Oct 23, 2024K243007CD Horizon™ Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Oct 17, 2024K242899NOVA Minimally Invasive System
Baui Biotech Co., Ltd., TW
NKB
Oct 10, 2024K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
Greens Surgicals Pvt. , Ltd., IN
NKB
Sep 30, 2024K241657MSFX MIKRON SPINAL FIXATION SYSTEM
Mikron Makina Sanayi VE Ticaret Ltd. Sti., TR
NKB
Sep 9, 2024K242042TriALTIS™ Spine System
Medos International SARL, CH
NKB
Sep 9, 2024K240233Pitkar Spinal Pedicle Screw System
S.H.Pitkar Orthotools Pvt. , Ltd., IN
NKB
Sep 3, 2024K242069Eminent Spine Scoliosis Deformity Pedicle Screw System
Eminent Spine
NKB
Aug 30, 2024K240180Orthopeasia Spinal Fixation System
Orthopeasia Co., Ltd., TH
NKB
Aug 2, 2024K241892Cortera™ Spinal Fixation System
Xtant Medical Holdings, Inc.
NKB
Aug 1, 2024K233793CarboClear® X Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Jul 26, 2024K241494Pantheon Pedicle Screw and Iliac Bolt Fixation System
Pantheon Spinal
NKB
Jul 24, 2024K241863Erisma® Lp Spinal Fixation System; Erisma® LP MIS
Clariance, FR
NKB
Jun 21, 2024K241519Invictus® Small Stature Spinal Fixation System
Alphatec Spine, Inc.
NKB
Jun 6, 2024K240963Spinal System
Teslake, Inc.
NKB
Jun 4, 2024K241258Ingenix Spinal System
Ingenium Spine
NKB
May 20, 2024K241276Vector™ Pedicle Screw System
Innovasis, Inc.
NKB
May 6, 2024K240685Salvo® Spine System
Spine Wave, Inc.
NKB
May 6, 2024K240392JAZZ Spinal System
Implanet, FR
NKB
Apr 29, 2024K240526POWEReam Xia/Serrato
Stryker Instruments
NKB
Apr 26, 2024K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
Clariance, FR
NKB
Apr 25, 2024K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicl
CarboFix Orthopedics , Ltd., IL
NKB
Apr 19, 2024K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner
SeaSpine Orthopedics Corporation
NKB
Apr 5, 2024K240737G Surgical Marksman MIS System
G Surgical, LLC
NKB
Apr 3, 2024K240350AnyPlus II Spinal Fixation System
GS Medical Co., Ltd., KR
NKB
Mar 27, 2024K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
Medtronic Sofamor Danek USA, Inc.
NKB
Mar 15, 2024K240539Vital™ Spinal Fixation System
Zimvie Spine (Zimmer Biomet Spine, Inc.)
NKB
Feb 27, 2024K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SP
Solco Biomedical Copany India Private Limited, IN
NKB
Feb 26, 2024K232628VADER® Pedicle System
Icotec AG, CH
NKB
Feb 13, 2024K234048M.U.S.T. Pedicle Screw System - Extension
Medacta International S.A., CH
NKB
Feb 6, 2024K233960INNOVERSE Spinal System
Innosys Co., Ltd., KR
NKB
Jan 10, 2024K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
CarboFix Orthopedics , Ltd., IL
NKB
Dec 26, 2023K233300POWEReam 1/4 Drive
Stryker Instruments
NKB
Dec 12, 2023K233684TriALTIS™ Spine System
Medos International SARL, CH
NKB
Dec 12, 2023K233455ARx MIS Spinal Screw System
Life Spine, Inc.
NKB
Nov 21, 2023K232719ProMIS Extension Rod System
Premia Spine, Ltd., IL
NKB
Nov 21, 2023K231443Mini-OSTEO Pedicle Fixation System
Osteomed Indústria E Comércio DE Implantes Ltda, BR
NKB
Nov 16, 2023K231694MASADA Modular Spinal Fixation System
Astura Medical
NKB
Oct 26, 2023K233234PressON Spinal Fixation System
Nexus Spine, LLC
NKB

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