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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 22, 2023K223558CUVIS-spine
Curexo, Inc., KR
OLO
May 26, 2023K231184CD Horizon™ Spinal System
Medtronic Sofamor Danek USA, Inc.
OLO
May 25, 2023K231229S-COMP Reform® POCT Navigation Instruments
Precision Spine, Inc.
OLO
May 5, 2023K230989Rod Registration Frame
Nu Vasive, Incorporated
OLO
May 2, 2023K230880CoreLink Navigation Instruments
Corelink, LLC
OLO
May 2, 2023K223511Excella Navigation Instruments
Innovasis, Inc.
OLO
Apr 25, 2023K230202TMINI™ Miniature Robotic System
THINK Surgical, Inc.
OLO
Apr 21, 2023K230783Anatase Spine Surgery Navigation System
Remex Medical Corp., TW
OLO
Apr 21, 2023K222291Paradigm System
Proprio, Inc.
OLO
Apr 7, 2023K230064Mazor X System (Mazor X Stealth Edition)
Mazor Robotics , Ltd., IL
OLO
Mar 29, 2023K230243ROSA® Knee System
Orthosoft D/B/A Zimmer Cas, CA
OLO
Mar 23, 2023K223765ATEC Lateral Navigation Instruments
Alphatec Spine, Inc.
OLO
Mar 13, 2023K223350Remi Robotic Navigation System
Fusion Robotics, LLC
OLO
Mar 8, 2023K222355PathKeeper System
Pathkeeper Surgical , Ltd., IL
OLO
Feb 22, 2023K230180Rosa Knee System
Orthosoft Inc (D/B/A Zimmer Cas), CA
OLO
Feb 13, 2023K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ort
Stryker Leibinger GmbH & Co KG, DE
OLO
Jan 31, 2023K223351Naviswiss Knee
Naviswiss AG, CH
OLO
Jan 27, 2023K223927360CAS
Kico Knee Innovation Company Pty Limited, AU
OLO
Jan 20, 2023K222510Blueprint Mixed Reality system
Tornier S.A.S., FR
OLO
Jan 19, 2023K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
Medos International SARL, CH
OLO
Jan 6, 2023K223200Curiteva Navigation System
Curiteva, Inc.
OLO
Dec 22, 2022K223649VERTICALE® Navigation Instruments
Silony Medical GmbH, DE
OLO
Dec 9, 2022K222753SeaSpine 7D Navigation Instruments
SeaSpine Orthopedics Corporation
OLO
Dec 9, 2022K220774RobPath® Total Hip Application
Hangzhou Lancet Robotics Co., Ltd., CN
OLO
Oct 28, 2022K223070Remi Robotic Navigation System
Fusion Robotics, LLC
OLO
Oct 27, 2022K222966Cirq Arm System (2.0);Alignment System Spine
Brainlab AG, DE
OLO
Oct 7, 2022K222698CUVIS-spine
Curexo, Inc., KR
OLO
Oct 4, 2022K221928ROSA® Knee System
Orthosoft D/B/A Zimmer Cas, CA
OLO
Sep 29, 2022K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition
Medtronic Sofamor Danek USA, Inc.
OLO
Aug 30, 2022K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Softw
Brainlab AG, DE
OLO
Aug 19, 2022K221224REAL INTELLIGENCE CORI
Blue Belt Technologies, Inc.
OLO
Aug 9, 2022K220241“POINT” Kinguide Robotic-Assisted Surgical System
Point Robotics MedTech, Inc., TW
OLO
Aug 5, 2022K213876Spineology Navigation Instruments
Spineology, Inc.
OLO
Jul 27, 2022K220958Real Intelligence Cori
Blue Belt Technologies, Inc.
OLO
Jul 14, 2022K220862E-GPS Navigated Instruments
Precision Spine, Inc.
OLO
Jul 14, 2022K220348Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
Remex Medical Corporation, TW
OLO
Jul 7, 2022K213873SkyWalker Total Knee System
Microport Navibot International, LLC
OLO
Jul 6, 2022K221028SURGIVISIO Device
Ecential Robotics, FR
OLO
Jul 6, 2022K220024ChoiceSpine Navigation System
Choice Spine, LLC
OLO
Jun 3, 2022K220652Knee 3
Brainlab AG, DE
OLO
Jun 1, 2022K220973CoreLink Navigation Instruments
Corelink, LLC
OLO
May 27, 2022K220593Spine Guidance Software, Stryker Q Guidance System
Stryker Leibinger GmbH & Co KG, DE
OLO
May 27, 2022K220146VisAR
Novarad Corporation
OLO
May 25, 2022K221180Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
Medtronic Sofamor Danek USA, Inc.
OLO
May 20, 2022K2205227D Surgical System - Percutaneous Application (7D Flash Frame)
7D Surgical, CA
OLO
May 12, 2022K213491Universal Pilot Guidance Instrument System
Ctl Medical Corporation
OLO
May 5, 2022K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
Medos International SARL, CH
OLO
May 2, 2022K213877ExactechGPS® System
Blue Ortho, FR
OLO
Apr 29, 2022K220038Camber Spine Navigation System
Camber Spine Technologies
OLO
Apr 22, 2022K213708ROSA® Knee System
Orthosoft Inc (D/B/A Zimmer Cas), CA
OLO

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