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 22, 2019 | K183644 | Stealth-Midas MR8 System Medtronic Powered Surgical Solutions | OLO |
| May 17, 2019 | K183381 | Navigation Enabled Instruments Stryker | OLO |
| Apr 9, 2019 | K190653 | ExcelsiusGPS Globus Medical, Inc. | OLO |
| Mar 22, 2019 | K182848 | ROSA ONE Spine application Medtech S.A, FR | OLO |
| Feb 14, 2019 | K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMas Stryker Corporation, DE | OLO |
| Jan 24, 2019 | K182964 | ROSA Knee System Orthosoft Inc (D/B/A Zimmer Cas), CA | OLO |
| Jan 8, 2019 | K182721 | Choice Spine Navigation System Choicespine, LP | OLO |
| Jan 4, 2019 | K182982 | BridalVeil Navigated Instruments Astura Medical | OLO |
| Nov 9, 2018 | K181890 | Brainlab Compatible K2M Navigation Instruments K2m | OLO |
| Nov 2, 2018 | K182121 | CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition Medtronic Sofamor Danek USA, Inc. | OLO |
| Nov 2, 2018 | K182104 | NavLock Trackers, Robotic Reference Frame Medtronic Navigation | OLO |
| Nov 2, 2018 | K182077 | Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd., IL | OLO |
| Oct 24, 2018 | K181596 | Spine Wave Navigated Instruments Spine Wave, Inc. | OLO |
| Oct 12, 2018 | K181848 | ADAPT for Gamma3, Gamma3 Stryker GmbH | OLO |
| Sep 21, 2018 | K182345 | Spineology Navigation Instruments Spineology, Inc. | OLO |
| Sep 19, 2018 | K181449 | Ortoma Treatment Solution - OTS Ortoma AB, SE | OLO |
| Jul 11, 2018 | K180816 | Ziehm RFD 3D Tracker Medtronic Navigation | OLO |
| Jun 29, 2018 | K180038 | NuVasive Pulse System Nu Vasive, Incorporated | OLO |
| Jun 25, 2018 | K180690 | Navigation Instruments Globus Medical, Inc. | OLO |
| May 17, 2018 | K181111 | Navigated INFINITY Instruments Medtronic Sofamor Danek USA, Inc. | OLO |
| May 11, 2018 | K172517 | SeaSpine Navigation System SeaSpine Orthopedics Corporation | OLO |
| May 2, 2018 | K180796 | Spineology Navigation Instruments Spineology, Inc. | OLO |
| May 2, 2018 | K180352 | 7D Surgical System 7D Surgical, Inc., CA | OLO |
| May 2, 2018 | K173946 | ADAPT for Gamma3 Stryker GmbH, CH | OLO |
| Apr 30, 2018 | K180307 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| Apr 27, 2018 | K172166 | OLYMPIC Navigated Instruments Astura Medical | OLO |
| Apr 24, 2018 | K180277 | Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter Smith & Nephew, Inc. | OLO |
| Apr 6, 2018 | K180271 | NAVIO Surgical System (NAVIO system) Blue Belt Technologies, Inc. | OLO |
| Mar 8, 2018 | K172115 | Navigated Instrument System Orthofix, Inc. | OLO |
| Jan 18, 2018 | K173338 | Navigated INFINITY Instruments Medtronic Sofamor Danek USA, Inc. | OLO |
| Jan 16, 2018 | K171556 | K2M Navigation Instruments K2m | OLO |
| Jan 5, 2018 | K172518 | Spineology Navigation Instruments Spineology, Inc. | OLO |
| Dec 21, 2017 | K172623 | NuVasive Navigation Instruments Nu Vasive, Incorporated | OLO |
| Nov 24, 2017 | K173372 | ExactechGPS Total Shoulder Application Blue Ortho, FR | OLO |
| Nov 22, 2017 | K172462 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Nov 16, 2017 | K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray Intellijoint Surgical, Inc., CA | OLO |
| Nov 2, 2017 | K172301 | Mako Partial Knee Application Mako Surgical Corp. | OLO |
| Oct 31, 2017 | K172268 | iFuse Implant System- iFuse Navigation SI-BONE, Inc. | OLO |
| Oct 30, 2017 | K171525 | Intellijoint HIP Generation 2B System Intellijoint Surgical, Inc., CA | OLO |
| Oct 18, 2017 | K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill G Stryker Corporation, DE | OLO |
| Sep 21, 2017 | K172219 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| Sep 15, 2017 | K172522 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| Sep 14, 2017 | K170937 | VIPER PRIME navigated inserter Medos International SARL, CH | OLO |
| Sep 1, 2017 | K163338 | OMNIBotics Knee System Omnllife Science, Inc. | OLO |
| Aug 30, 2017 | K171321 | K2M Navigation Instruments K2m | OLO |
| Aug 16, 2017 | K171651 | EXCELSIUS GPS Globus Medical, Inc. | OLO |
| Jul 11, 2017 | K171780 | OrthAlign Plus System Orthalign, Inc. | OLO |
| Jul 3, 2017 | K171267 | NavLock Trackers Medtronic Navigation | OLO |
| May 24, 2017 | K170891 | Mako Partial Knee Application Mako Surgical Corp. | OLO |
| May 11, 2017 | K170584 | Mako Partial Knee Application Mako Surgical Corp. | OLO |
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