ClearanceBrief
Panels › Neurology › Product code OLO · Class 2

Orthopedic Stereotaxic Instrument

Regulation 882.4560

48510(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
Oct 19, 2026K2604037D Surgical System (10-0001)
7D Surgical ULC, CA
OLO
Oct 16, 2026K263234TMINI Miniature Robotic System
THINK Surgical, Inc.
OLO
Oct 9, 2026K263154CarboClear® Cervical Navigated Instruments
CarboFix Orhtopedics , Ltd., IL
OLO
Sep 30, 2026K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
Brainlab SE, DE
OLO
Aug 20, 2026K262506Remex Spine Surgery Navigation - Universal Instruments
Remex Medical Corp., TW
OLO
Jul 30, 2026K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
Suite 201, National Innovation Centre, AU
OLO
Jul 29, 2026K261205SPINEART Navigation Instrument System
Spineart SA, CH
OLO
Jul 24, 2026K262121Ion-L Navigated Instruments
SurGenTec, LLC
OLO
Jul 24, 2026K261024TMINI Miniature Robotic System
THINK Surgical, Inc.
OLO
Jul 22, 2026K261113Op.n™ Spine Navigation and Robotic Guidance
Ecential Robotics, FR
OLO
Jul 1, 2026K261852OTS Hip
Ortoma AB, SE
OLO
Jun 26, 2026K253921VERTICALE® Navigation Instruments
Silony Medical GmbH, DE
OLO
Jun 25, 2026K260480VELYS™ Robotic-Assisted Solution
Depuy Ireland UC, IE
OLO
Jun 20, 2026K260369Dynamis Robotic Surgical System
LEM Surgical AG, CH
OLO
Jun 18, 2026K261665CORUS™ Navigation System-GN
Providence Medical Technology, Inc.
OLO
Jun 2, 2026K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
Life Spine, Inc.
OLO
May 29, 2026K261060Navigated LLIF Impactable Tracker
Tyber Medical, LLC
OLO
May 26, 2026K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
Medos International SARL, CH
OLO
May 22, 2026K260329Ion-C Navigation Instruments
SurGenTec, LLC
OLO
May 21, 2026K260582ROSA® Shoulder System
Orthosoft Inc. (d/b/a) Zimmer CAS, CA
OLO
May 11, 2026K252880Pytheas Your Guided Trajectory
Pytheas Navigation Sas, FR
OLO
Apr 16, 2026K260011Foundation Surgical Navigated Lateral Disc Prep Instruments
Foundation Surgical Group, Inc.
OLO
Apr 9, 2026K254158SPINEART Navigation Instrument System
Spineart SA, CH
OLO
Mar 27, 2026K260240SYMPHONY Navigation Ready Instruments
Medos International SARL, CH
OLO
Mar 26, 2026K260601REAL INTELLIGENCE™ CORI™
Blue Belt Technologies, Inc.
OLO
Mar 25, 2026K252037CUVIS-joint (CJ150)
Curexo, Inc., KR
OLO
Mar 20, 2026K253604TiLink-L Navigation Instruments
SurGenTec, LLC
OLO
Mar 18, 2026K253444EUROPA™ Posterior Cervical Fusion Navigated Instruments
MiRus, LLC
OLO
Mar 17, 2026K260546Q Pedicle Instruments
K2m, Inc.
OLO
Mar 3, 2026K260010TMINI® Miniature Robotic System
THINK Surgical, Inc.
OLO
Feb 25, 2026K260222Mako Total Knee Application
Mako Surgical Corp.
OLO
Feb 20, 2026K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set
Point Robotics MedTech, Inc., TW
OLO
Feb 19, 2026K254148VERTICALE GPS Instruments
Silony Medical GmbH, DE
OLO
Feb 19, 2026K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable;
Stryker Leibinger GmbH & Co KG, DE
OLO
Feb 19, 2026K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
Alphatec Spine, Inc.
OLO
Feb 12, 2026K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
Medtronic Navigation, Inc.
OLO
Feb 6, 2026K252873Q Interbody Instruments
K2m, Inc.
OLO
Feb 6, 2026K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
Stryker Leibinger GmbH & Co KG, DE
OLO
Feb 6, 2026K252058ROSA Knee System with UltraSound Imaging Platform (USIP)
Balmoral Medical, LLC
OLO
Feb 3, 2026K252087Navigation Module of the Cortium® System
Ulrich Medical USA, Inc.
OLO
Jan 23, 2026K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
Point Robotics MedTech, Inc., TW
OLO
Jan 12, 2026K252962DYNAMIS™ Navigation System
Promethean Restorative, LLC
OLO
Dec 22, 2025K253661TMINI Miniature Robotic System
THINK Surgical, Inc.
OLO
Dec 15, 2025K252950Paradigm System
Proprio, Inc.
OLO
Dec 5, 2025K252841REAL INTELLIGENCE™ CORI™ XT (CORI XT)
Blue Belt Technologies, Inc.
OLO
Dec 4, 2025K251943Spineology Navigation Instruments
Spineology, Inc.
OLO
Nov 13, 2025K251314Rosa® Knee System
Orthosoft Inc. (d/b/a) Zimmer CAS, CA
OLO
Nov 5, 2025K250599ExcelsiusGPS™ Instruments
Globus Medical, Inc.
OLO
Oct 31, 2025K252088Firebird SI Navigation System
Orthofix US, LLC
OLO
Oct 28, 2025K252742Navigated Instruments
Tyber Medical, LLC
OLO

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