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)
Top companies in OLO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2020 | K192653 | Perseus Orthokey Italia S.R.L., IT | OLO |
| Sep 3, 2020 | K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array 7D Surgical, Inc., CA | OLO |
| Sep 2, 2020 | K193618 | ExactechGPS System Blue Ortho, FR | OLO |
| Aug 7, 2020 | K201006 | K2M Navigation Instruments K2m, Inc. | OLO |
| Aug 5, 2020 | K201251 | CarboClear Navigated Instruments CarboFix Orthopedics , Ltd., IL | OLO |
| Jul 31, 2020 | K200791 | Navigation Enabled Intruments Medos International SARL, CH | OLO |
| Jul 30, 2020 | K192663 | Joimax Intracs System Joimax GmbH, DE | OLO |
| Jul 14, 2020 | K193515 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| Jul 10, 2020 | K200047 | ExcelsiusGPS Cranial 1.0 Module Globus Medical, Inc. | OLO |
| Jun 27, 2020 | K200888 | OMNIBotics Knee System Corin, Ltd. | OLO |
| Jun 26, 2020 | K200095 | Streamline Navigated Instruments Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | OLO |
| Jun 18, 2020 | K201327 | NavLock Trackers Medtronic Navigation | OLO |
| Jun 18, 2020 | K200892 | Harvey(R) Surgical Assistant Orthalign, Inc. | OLO |
| Jun 12, 2020 | K201022 | REAL INTELLIGENCE CORI (CORI) Blue Belt Technologies, Inc. | OLO |
| Jun 10, 2020 | K201255 | TSolution® One Total Knee Application THINK Surgical, Inc. | OLO |
| Jun 10, 2020 | K193094 | Naviswiss Hip Navigation System Naviswiss AG, CH | OLO |
| Jun 2, 2020 | K193307 | HIP7 Brainlab AG, DE | OLO |
| May 29, 2020 | K201189 | Stealthstation S8 Spine Software v1.3.0 Medtronic Navigation, Inc. | OLO |
| May 8, 2020 | K200935 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| Apr 10, 2020 | K200642 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Feb 14, 2020 | K193120 | Real Intelligence Cori Blue Belt Technologies, Inc. | OLO |
| Feb 2, 2020 | K193128 | Mako Total Hip Application Mako Surgical Corp. | OLO |
| Jan 17, 2020 | K192495 | Black Diamond Navigation Instruments Osseus Fusion Systems | OLO |
| Dec 19, 2019 | K190881 | Spinal Elements Navigated Instruments Spinal Elements, Inc. | OLO |
| Dec 13, 2019 | K182731 | Corelink Navigation Instruments Corelink, LLC | OLO |
| Dec 11, 2019 | K193135 | TSolution One Total Knee Application THINK Surgical, Inc. | OLO |
| Dec 2, 2019 | K191722 | Vital Navigation System Zimmer Biomet Spine, Inc. | OLO |
| Nov 22, 2019 | K192336 | Navigated Anterolateral Disc Prep Instruments Medtronic Sofamor Danek USA, Inc. | OLO |
| Nov 14, 2019 | K192911 | Brainlab Compatible K2M Navigation Instruments K2m, Inc. | OLO |
| Nov 5, 2019 | K192140 | 7D Surgical System 7D Surgical, Inc., CA | OLO |
| Nov 5, 2019 | K192080 | iASSIST Knee System Orthosoft Inc (D/B/A Zimmer Cas), CA | OLO |
| Oct 29, 2019 | K192173 | ROSA ONE Spine application Medtech S.A, FR | OLO |
| Oct 29, 2019 | K192133 | Zimmer Biomet Universal Navigation System Zimmer Biomet Spine, Inc. | OLO |
| Oct 24, 2019 | K190556 | Zimmer Biomet Universal Navigation System Zimmer Biomet Spine, Inc. | OLO |
| Oct 18, 2019 | K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set Medos International SARL, CH | OLO |
| Oct 10, 2019 | K192526 | Spine Wave Navigated Instruments Spine Wave, Inc. | OLO |
| Oct 8, 2019 | K191854 | Premia Spine XL Instruments Premia Spine, Ltd., IL | OLO |
| Oct 8, 2019 | K191369 | TSolution One Total Knee Application THINK Surgical, Inc. | OLO |
| Oct 1, 2019 | K191507 | Intellijoint® Navigation System Intellijoint Surgical, Inc., CA | OLO |
| Sep 27, 2019 | K181606 | Precision Spine Navigation Instrumentation Precision Spine, Inc. | OLO |
| Sep 24, 2019 | K191998 | Mako Total Hip Application, Mako Total Knee Application Mako Surgical Corp. | OLO |
| Sep 20, 2019 | K180523 | INTAI Surgery Navigation System Intai Technology Corporation, TW | OLO |
| Aug 29, 2019 | K183605 | Spine & Trauma Navigation Brainlab AG, DE | OLO |
| Aug 26, 2019 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates Medtronic Sofamor Danek USA, Inc. | OLO |
| Aug 7, 2019 | K191012 | Navigated Pedicle Access Kit Izi Medical Products, LLC | OLO |
| Jul 24, 2019 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module Globus Medical, Inc. | OLO |
| Jun 28, 2019 | K191223 | NAVIO Blue Belt Technologies, Inc. | OLO |
| Jun 17, 2019 | K182524 | GALILEO Spine Alignment Monitoring System MiRus, LLC | OLO |
| Jun 11, 2019 | K191285 | Spine & Trauma Navigation Brainlab AG, DE | OLO |
| Jun 10, 2019 | K183630 | SPINEART Navigation Instrument System Spineart SA, CH | OLO |
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