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Panels › Neurology › Product code OLO · Class 2

Orthopedic Stereotaxic Instrument

Regulation 882.4560

47510(k)s in 12 months (444 all time)
13recalls in 12 months (115 all time)
113recalls that name a 510(k)
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Top companies in OLO

Company510(k)sRecalls
Mako Surgical Corp.2325
Brainlab AG216
Medtronic Navigation1214
THINK Surgical, Inc.204
Blue Belt Technologies, Inc.183
Medtronic Sofamor Danek USA, Inc.161
Globus Medical, Inc.132
Mazor Robotics , Ltd.104
Orthalign, Inc.122
Orthosoft D/B/A Zimmer Cas130
Decided510(k)Device and applicantCode
Jun 17, 2024K233256Robotic Integration Instruments
DePuy Synthes, CH
OLO
Jun 17, 2024K233255CROSSNAV Navigation Enabled Instruments
DePuy Synthes, CH
OLO
Jun 14, 2024K241082INNOVERSE Navigation Instruments
Innosys Co., Ltd., KR
OLO
Jun 14, 2024K240721ExcelsiusFlex™
Globus Medical, Inc.
OLO
Jun 14, 2024K233254TELIGEN System Navigation Ready Instruments
DePuy Synthes, CH
OLO
Jun 14, 2024K233228Spine Navigation and Robotic-Assistance Device
Ecential Robotics, FR
OLO
Jun 11, 2024K241011Mako Total Knee Application
Mako Surgical Corp.
OLO
Jun 6, 2024K240951Invictus Robotic Navigation Instruments
Alphatec Spine
OLO
Jun 6, 2024K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedi
Stryker Leibinger GmbH & Co KG, DE
OLO
Jun 5, 2024K240211VELYS Robotic-Assisted Solution
Depuy Ireland UC, IE
OLO
May 23, 2024K240701Drill Guide; Drill Bit; Spine & Trauma Navigation
Brainlab AG, DE
OLO
May 3, 2024K240625CORUS Navigation Access System
Providence Medical Technology, Inc.
OLO
May 1, 2024K233513Remex Spine Surgery Navigation System II
Remex Medical Corp., TW
OLO
Apr 29, 2024K240568DuraPro™ Oscillating System
Globus Medical, Inc.
OLO
Apr 29, 2024K240062ARVIS® Shoulder
Insight Medical Systems, Inc.
OLO
Apr 5, 2024K240647Virage® Navigation System
Zimvie Spine (Zimmer Biomet Spine, Inc.)
OLO
Mar 29, 2024K233595Genesys Spine Sacroiliac Joint Fusion System with Navigation
Genesys Spine
OLO
Mar 20, 2024K234047Automatic Registration
Brainlab AG, DE
OLO
Mar 18, 2024K240139Real Intelligence™ CORI™
Blue Belt Technologies, Inc.
OLO
Mar 14, 2024K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q G
Stryker Leibinger GmbH & Co KG, DE
OLO
Mar 11, 2024K232140OTS Hip
Ortoma AB, SE
OLO
Mar 8, 2024K230195Neo ADVISE software
Comerge AG, CH
OLO
Feb 23, 2024K232800Navigation Tracking Instruments
SI-BONE, Inc.
OLO
Feb 21, 2024K233199ROSA® Shoulder System
Orthosoft Inc (D/B/A Zimmer Cas), CA
OLO
Feb 9, 2024K233638VERZA™ High Speed Drills
Globus Medical, Inc.
OLO
Jan 26, 2024K233299ExactechGPS® System
Blue Ortho, FR
OLO
Dec 14, 2023K233227VELYS™ Robotic-Assisted Solution
Depuy Ireland UC, IE
OLO
Dec 13, 2023K232572Kalitec Navigated Instrument System
Kalitec Direct, LLC Doing Business AS Kalitec Medical
OLO
Nov 20, 2023K230700RIWOtrack Navigation System
Fiagon GmbH, DE
OLO
Nov 16, 2023K233443Vital™ Navigation System
Zimvie Spine (Zimmer Biomet Spine, Inc.)
OLO
Nov 16, 2023K232533ROSA Partial Knee System
Orthosoft D/B/A Zimmer Cas, CA
OLO
Nov 16, 2023K232521ExactechGPS® Total Ankle Application
Blue Ortho, FR
OLO
Nov 2, 2023K232345ATEC Posterior Navigated Disc Prep Instruments
Alphatec Spine, Inc.
OLO
Oct 27, 2023K231494CoreLink Robotic Navigation Instruments
Corelink, LLC
OLO
Oct 12, 2023K232802TMINI™ Miniature Robotic System
THINK Surgical, Inc.
OLO
Oct 6, 2023K232044Invictus Robotic Navigation Instruments
Alphatec Spine, Inc.
OLO
Sep 29, 2023K231527TriALTIS Navigation Enabled Instruments
Medos International Sàrl, CH
OLO
Sep 8, 2023K232413Fusion Robotic Navigation System
Alphatec Spine, Inc.
OLO
Aug 16, 2023K232116CoreLink Navigation Instruments
Corelink, LLC
OLO
Aug 2, 2023K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Brainlab AG, DE
OLO
Aug 1, 2023K231963REAL INTELLIGENCE™ CORI™
Blue Belt Technologies, Inc.
OLO
Jul 27, 2023K231886SURGIVISIO Device
Ecential Robotics, FR
OLO
Jul 26, 2023K231172ApolloKnee
Corin U.S.A. Limited
OLO
Jul 20, 2023K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
Spinecraft, LLC
OLO
Jul 18, 2023K230716Robotic Graft Delivery Instruments
Medtronic Sofamor Danek, Inc.
OLO
Jul 17, 2023K230087“POINT” Kinguide Agile Hybrid Navigation System
Point Robotics MedTech, Inc., TW
OLO
Jul 12, 2023K223808Zavation Navigation Instrument System
Zavation Medical Products, LLC
OLO
Jun 27, 2023K230876RI.KNEE Adjustable Tibia Cut Guide
Enztec Limited, NZ
OLO
Jun 27, 2023K230861VADER® Pedicle System Navigated Instruments
Icotec AG, CH
OLO
Jun 23, 2023K230369EUROPA™ Navigated Instruments
MiRus, LLC
OLO

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