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 |
|---|---|---|---|
| May 11, 2017 | K170581 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| May 3, 2017 | K170977 | SURESHOT Distal Targeting System V4.0 Trauma Interface Smith & Nephew, Inc. | OLO |
| May 2, 2017 | K170360 | NAVIO Blue Belt Technologies, Inc. | OLO |
| May 1, 2017 | K170011 | StealthStation S8 Spine Software v1.0.0 Medtronic Navigation | OLO |
| Apr 28, 2017 | K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 Smith & Nephew, Inc. | OLO |
| Apr 18, 2017 | K170593 | Mako Total Hip Application Mako Surgical Corp. | OLO |
| Apr 14, 2017 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments Medtronic Sofamor Danek USA, Inc. | OLO |
| Apr 5, 2017 | K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software Blue Ortho, FR | OLO |
| Apr 4, 2017 | K163221 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| Mar 13, 2017 | K162921 | Navigated Instrument System Orthofix, Inc. | OLO |
| Mar 6, 2017 | K170430 | TSolution One Surgical System Model 210 THINK Surgical, Inc. | OLO |
| Mar 2, 2017 | K163379 | KneeAlign 2 System Orthalign, Inc. | OLO |
| Mar 2, 2017 | K162364 | Intellijoint HIP Generation 2A System Intellijoint Surgical, Inc., CA | OLO |
| Feb 23, 2017 | K162937 | Stryker OrthoMap Versatile Hip System Stryker Corporation | OLO |
| Jan 23, 2017 | K162962 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Dec 29, 2016 | K162375 | Envision 3D: Image Guidance System 7D Surgical, Inc., CA | OLO |
| Oct 12, 2016 | K162341 | Stryker OrthoMap Precision Knee system Stryker Leibinger GmbH & Co KG, DE | OLO |
| Sep 14, 2016 | K162195 | TSolution One Cup1 Surgical System THINK Surgical, Inc. | OLO |
| Jul 27, 2016 | K160385 | Precision Screw Cryptych Pty, Ltd., AU | OLO |
| Jul 8, 2016 | K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments Aesculap Implant Systems, LLC | OLO |
| Jul 7, 2016 | K153240 | Styrker OrthoMap Express Knee System Stryker Corporate, DE | OLO |
| May 26, 2016 | K160713 | Stealth-Midas System Medtronic Powered Surgical Solutions | OLO |
| May 19, 2016 | K160537 | Navio Blue Belt Technologies, Inc. | OLO |
| May 16, 2016 | K153396 | Aesculap OrthoPilot Next Generation Aesculap Implant Systems, LLC | OLO |
| Apr 29, 2016 | K153603 | Alphatec Navigation Instruments Alphatec Spine, Inc. | OLO |
| Mar 1, 2016 | K153237 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Feb 16, 2016 | K153647 | TSolution One w/ACG+ Surgical System THINK Surgical, Inc. | OLO |
| Feb 3, 2016 | K153203 | Navigation Instruments Globus Medical, Inc. | OLO |
| Jan 4, 2016 | K151511 | ROSA Spine Medtech S.A, FR | OLO |
| Dec 28, 2015 | K151364 | Intellijoint HIP(tm) System Intellijoint Surgical, Inc., CA | OLO |
| Nov 17, 2015 | K152041 | Renaissance X System Mazor Robotics , Ltd., IL | OLO |
| Oct 20, 2015 | K152574 | Navio Blue Belt Technologies, Inc. | OLO |
| Sep 16, 2015 | K142530 | Partial Knee Application (PKA) Mako Surgical Corporation | OLO |
| Sep 4, 2015 | K143597 | Navigated XIA 4.5 Polyaxial Screwdriver Stryker Corporate, DE | OLO |
| Aug 6, 2015 | K143752 | Total Knee Application (TKA) Mako Surgical Corp. | OLO |
| Jun 16, 2015 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials Medtronic Sofamor Danek USA, Inc. | OLO |
| Mar 20, 2015 | K143668 | Navio Blue Belt Technologies, Inc. | OLO |
| Feb 24, 2015 | K141694 | AESCULAP ORTHOPILOT NEXT GENERATION Aesculap Implant Systems, LLC | OLO |
| Feb 12, 2015 | K143628 | Navigated Vertex Select Instruments Medtronic Sofamor Danek USA, Inc. | OLO |
| Nov 13, 2014 | K141989 | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM Mako Surgical Corporation | OLO |
| Oct 31, 2014 | K141941 | SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D Stryker Corporate, DE | OLO |
| Oct 24, 2014 | K140927 | UNIVERSAL NAVIGATION INSTRUMENTS Medos International SARL | OLO |
| Sep 11, 2014 | K141601 | IASSIST KNEE SYSTEM Zimmer Cas, CA | OLO |
| Sep 10, 2014 | K140167 | RENAISSANCE X SYSTEM Mazor Robotics , Ltd., IL | OLO |
| Aug 22, 2014 | K140689 | IKNEE DISTAL FEMORAL CUTTING GUIDE Evergreen Orthopedic Research Lab | OLO |
| Jul 23, 2014 | K133759 | INTELLIJOINT HIP Intellijoint Surgical, Inc., CA | OLO |
| Jul 2, 2014 | K140596 | NAVIO Blue Belt Technologies, Inc. | OLO |
| Jun 10, 2014 | K140331 | ORTHALIGN PLUS SYSTEM Orthalign, Inc. | OLO |
| May 22, 2014 | K140454 | NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS Medtronic Sofamor Danek USA, Inc. | OLO |
| Nov 8, 2013 | K130387 | ORTHOALIGN PLUS SYSTEM Orthalign, Inc. | OLO |
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