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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
Oct 27, 2025K250520OsteoCentric Navigated Instruments System
Osteocentric Technologies, Inc.
OLO
Oct 17, 2025K251282StealthStation S8 Spine Software
Medtronic Navigation, Inc.
OLO
Oct 10, 2025K252544TMINI Miniature Robotic System
THINK Surgical, Inc.
OLO
Sep 25, 2025K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attac
Stryker Instruments
OLO
Sep 15, 2025K251780iGPS Navigation Instruments
SI-BONE, Inc.
OLO
Sep 12, 2025K252562Spine & Trauma Navigation Instruments
Brainlab AG, DE
OLO
Sep 11, 2025K251316Mazor X System / Mazor X Stealth Edition
Mazor Robotics , Ltd., IL
OLO
Aug 18, 2025K250167Evolution Spine Navigation Instruments
Evolution Spine
OLO
Jul 30, 2025K251060CORUS™ Navigation System-GX
Providence Medical Technology, Inc.
OLO
Jul 23, 2025K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
Innovasis, Inc.
OLO
Jun 20, 2025K250877TMINI Miniature Robotic System
THINK Surgical, Inc.
OLO
Jun 18, 2025K242933SPINEART Navigation Instrument System
Spineart SA, CH
OLO
Jun 5, 2025K242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
Medtronic Navigation, Inc.
OLO
Jun 4, 2025K250879Paradigm System
Proprio, Inc.
OLO
May 29, 2025K251315Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
Remex Medical Corp., TW
OLO
May 16, 2025K250086OTS Hip
Ortoma AB, SE
OLO
May 8, 2025K243419Altus Spine Navigation System
Altus Partners, LLC
OLO
Apr 25, 2025K250608Mako Total Knee Application (3.0); Hybrid Tip Pointer
Mako Surgical Corp.
OLO
Apr 23, 2025K243326Dynamis Robotic Surgical System
LEM Surgical AG, CH
OLO
Apr 16, 2025K242806Medyssey Navigation System
Medyssey Co, Ltd., KR
OLO
Apr 3, 2025K243514Salvo® Robotic Navigation Instruments
Spine Wave, Inc.
OLO
Apr 2, 2025K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
SeaSpine Orthopedics Corporation
OLO
Mar 24, 2025K250182Innovasis Navigation Instruments
Innovasis, Inc.
OLO
Mar 21, 2025K243958Consolidated Operating Room Equipment (CORE) 2 Console
Stryker Instruments
OLO
Mar 14, 2025K242121mBôs (Monogram mBôs TKA System)
Monogram Orthopaedics, Inc.
OLO
Mar 7, 2025K242914Op.n(TM) Navigation
Ecential Robotics, FR
OLO
Mar 7, 2025K242890SPINEART Navigation Instrument System
Spineart SA, CH
OLO
Mar 5, 2025K243751Mako Total Hip Application 5.0
Mako Surgical Corp.
OLO
Feb 21, 2025K243258Paradigm System
Proprio, Inc.
OLO
Jan 29, 2025K243387GYDER® Hip System
Gyder Surgical Pty, Ltd., AU
OLO
Jan 10, 2025K243814NuVasive Pulse System
Globus Medical, Inc.
OLO
Jan 6, 2025K243481TMINI Miniature Robotic System
THINK Surgical, Inc.
OLO
Dec 20, 2024K243671ExcelsiusGPS® Instruments
Globus Medical, Inc.
OLO
Dec 13, 2024K243560Remex Spine Surgery Navigation Instrument
Remex Medical Corp., TW
OLO
Dec 6, 2024K243073AnyPlus Navigated Instruments System
GS Medical Co., Ltd., KR
OLO
Nov 15, 2024K243285TMINI Miniature Robotic System
THINK Surgical, Inc.
OLO
Nov 7, 2024K242373Mako Shoulder Application (1.0)
Mako Surgical Corp.
OLO
Oct 18, 2024K242864ROSA® Knee System
Orthosoft Inc. (d/b/a) Zimmer CAS, CA
OLO
Oct 17, 2024K240160EGPS Navigated Instruments
Astura Medical
OLO
Sep 16, 2024K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
Medos International SARL, CH
OLO
Aug 27, 2024K241517Q Guidance System; Mako Spine System;
Stryker Leibinger GmbH & Co KG, DE
OLO
Aug 23, 2024K242264TMINI Miniature Robotic System
THINK Surgical, Inc.
OLO
Aug 8, 2024K242009360CAS Knee
Kico Knee Innovation Company Pty, Ltd., AU
OLO
Aug 7, 2024K241644SPINEART Navigation Instrument System
Spineart SA, CH
OLO
Aug 2, 2024K233706Bendini Cloud Application
Nuvasive
OLO
Jul 26, 2024K233725Spine Navigation System
Medivis, Inc.
OLO
Jul 25, 2024K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Dri
Stryker Leibinger GmbH & Co KG, DE
OLO
Jul 24, 2024K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
Point Robotics MedTech, Inc., TW
OLO
Jul 12, 2024K241031TMINI Miniature Robotic System (TMINI 1.1)
THINK Surgical, Inc.
OLO
Jul 5, 2024K241625Anatase Navi Disposable Instrument
Remex Medical Corp., TW
OLO

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