ClearanceBrief
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)
Get daily alerts for NKBSample briefCSV

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
Aug 31, 2022K221745Sterile Posterior Spinal Fixation System
Shanghai Reach Medical Instrument Co, Ltd., CN
NKB
Aug 29, 2022K222362Salvo® Spine System
Spine Wave, Inc.
NKB
Aug 19, 2022K221403Cortera Spinal Fixation System
Surgalign Spine Technologies
NKB
Aug 9, 2022K221776NextGen Pedicle Screw System
Corelink, LLC
NKB
Jul 28, 2022K221905INERTIA CONNEXX Modular Pedicle Screw System
Nexxt Spine, LLC
NKB
Jul 28, 2022K221332OsteoCentric Spine MIS Pedicle Fastener System
OsteoCentric Technologies
NKB
Jul 22, 2022K220486Kentrospine PSS Pedicle Screw System
Rivarp Medical Private Limited, IN
NKB
Jun 23, 2022K201788EDEN Spinal Fixation System
Jmt Co., Ltd., KR
NKB
Jun 9, 2022K211981KHEIRON® Spinal Fixation System
S.M.A.I.O, FR
NKB
Jun 1, 2022K2032334CIS Chiron Spinal Fixation System
Solco Biomedical Co., Ltd., KR
NKB
May 25, 2022K221244CD Horizon™ Spinal System
Medtronic
NKB
May 19, 2022K220285PINE Pedicle Screw System
Tdm Co., Ltd., KR
NKB
May 2, 2022K220341ARx Modular Spinal System
Life Spine, Inc.
NKB
Apr 8, 2022K220724CD Horizon™ Spinal System and PASS LP™ Spinal System
Medicrea International, FR
NKB
Apr 4, 2022K214006Invictus® Spinal Fixation System
Alphatec Spine, Inc.
NKB
Mar 31, 2022K220025ARx® Spinal System
Life Spine, Inc.
NKB
Mar 8, 2022K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
Medos International SARL, CH
NKB
Feb 28, 2022K213750VyLink™ Spinal Screw System
Vy Spine, LLC
NKB
Feb 18, 2022K212627True Tulip, True M.I.S.
Innovative Surgical Designs, Inc.
NKB
Jan 21, 2022K213470PERLA® TL Posterior Osteosynthesis System
Spineart, CH
NKB
Jan 5, 2022K213281PASS LP™ Spinal System, CD Horizon™ Spinal System
Medicrea International SA, FR
NKB
Dec 10, 2021K213460Invictus Spinal Fixation System
Alphatec Spine, Inc.
NKB
Sep 21, 2021K212692Mariner Pedicle Screw System
SeaSpine Orthopedics Corporation
NKB
Aug 20, 2021K203607MOSS VRS Spinal System
Biedermann Motech GmbH & Co. KG, DE
NKB
Aug 19, 2021K212185Golden Isles Pedicle Screw System
Intelivation, LLC
NKB
Aug 16, 2021K212066Adena-Zina System
Shanghai Sanyou Medical Co, Ltd., CN
NKB
Aug 10, 2021K211414KHEIRON Spinal Fixation System
S.M.A.I.O, FR
NKB
Jul 21, 2021K211958CD Horizon Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Jul 19, 2021K210963ENNOVATE Spinal System
Aesculap Implant Systems, LLC
NKB
Jul 14, 2021K203023Pisces Spinal System
Ortho Development Corporation
NKB
Jul 12, 2021K211113Zavation Spinal System
Zavation Medical Products, LLC
NKB
Jun 23, 2021K211606Mariner Deformity System
SeaSpine Orthopedics Corporation
NKB
Jun 21, 2021K201737Posterior Spinal Fixation System
Shanghai Reach Medical Instrument Co, Ltd., CN
NKB
Jun 3, 2021K211323ASTRA Spine System
Spinecraft, LLC
NKB
May 19, 2021K210306GII Spinal Fixation System
Coligne AG, CH
NKB
May 18, 2021K210816True Tulip, True M.I.S.
Innovative Surgical Designs, Inc.
NKB
May 13, 2021K210874Reliance Spinal Screw System
Reliance Medical Systems, LLC
NKB
Apr 30, 2021K210637CD Horizon™ Spinal System
Medtronic
NKB
Apr 22, 2021K210549ARx Spinal System
Life Spine, Inc.
NKB
Apr 20, 2021K210427M.U.S.T. Midline Cortical (MC) Screw System
Medacta International S.A., CH
NKB
Apr 19, 2021K210420Goblin and Goblin LS Pedicle Screw Systems
Medynus, Inc.
NKB
Apr 15, 2021K210539CoreLink Midline Fixation System
Corelink, LLC
NKB
Apr 6, 2021K210716CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
CarboFix Orthopedics , Ltd., IL
NKB
Apr 6, 2021K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw System
Auxein Medical Private Limited/71164, IN
NKB
Apr 2, 2021K210275Polaris Spinal System
Zimmer Biomet Spine, Inc.
NKB
Mar 5, 2021K201420Republic Spine Dark Star Spinal System
Republic Spine, LLC
NKB
Feb 18, 2021K2024984CIS SARA Spine System, 4CIS VERTU Spine System
Solco Biomedical Company India Private Limited, IN
NKB
Jan 28, 2021K203507Vitality® Spinal Fixation System
Zimmer Biomet Spine, Inc.
NKB
Jan 26, 2021K203482M.U.S.T. Pedicle Screw Extension and Long Tab Implants
Medacta International S.A., CH
NKB
Jan 26, 2021K200922Altus Spine HA Pedicle Screw System
Altus Partners, LLC
NKB

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.