FDA Product Code
FDA Product Code OLO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 441 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182848 | ROSA ONE Spine application | Medtech S.A | 2019-03-22 | Traditional | PDF ↗ |
| K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker | Stryker Corporation | 2019-02-14 | Traditional | PDF ↗ |
| K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-01-24 | Traditional | PDF ↗ |
| K182721 | Choice Spine Navigation System | Choicespine, LP | 2019-01-08 | Traditional | PDF ↗ |
| K182982 | BridalVeil Navigated Instruments | Astura Medical | 2019-01-04 | Traditional | PDF ↗ |
| K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018-11-09 | Traditional | PDF ↗ |
| K182104 | NavLock Trackers, Robotic Reference Frame | Medtronic Navigation | 2018-11-02 | Traditional | PDF ↗ |
| K182121 | CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition | Medtronic Sofamor Danek USA, Inc. | 2018-11-02 | Traditional | PDF ↗ |
| K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics , Ltd. | 2018-11-02 | Traditional | PDF ↗ |
| K181596 | Spine Wave Navigated Instruments | Spine Wave, Inc. | 2018-10-24 | Traditional | PDF ↗ |
| K181848 | ADAPT for Gamma3, Gamma3 | Stryker GmbH | 2018-10-12 | Traditional | PDF ↗ |
| K182345 | Spineology Navigation Instruments | Spineology, Inc. | 2018-09-21 | Special | PDF ↗ |
| K181449 | Ortoma Treatment Solution - OTS | Ortoma AB | 2018-09-19 | Traditional | PDF ↗ |
| K180816 | Ziehm RFD 3D Tracker | Medtronic Navigation | 2018-07-11 | Traditional | PDF ↗ |
| K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | 2018-06-29 | Traditional | PDF ↗ |
| K180690 | Navigation Instruments | Globus Medical, Inc. | 2018-06-25 | Traditional | PDF ↗ |
| K181111 | Navigated INFINITY Instruments | Medtronic Sofamor Danek USA, Inc. | 2018-05-17 | Special | PDF ↗ |
| K172517 | SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2018-05-11 | Traditional | PDF ↗ |
| K180352 | 7D Surgical System | 7D Surgical, Inc. | 2018-05-02 | Special | PDF ↗ |
| K173946 | ADAPT for Gamma3 | Stryker GmbH | 2018-05-02 | Traditional | PDF ↗ |
| K180796 | Spineology Navigation Instruments | Spineology, Inc. | 2018-05-02 | Special | PDF ↗ |
| K180307 | Mazor X | Mazor Robotics , Ltd. | 2018-04-30 | Special | PDF ↗ |
| K172166 | OLYMPIC Navigated Instruments | Astura Medical | 2018-04-27 | Traditional | PDF ↗ |
| K180277 | Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter | Smith & Nephew, Inc. | 2018-04-24 | Special | PDF ↗ |
| K180271 | NAVIO Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | 2018-04-06 | Special | PDF ↗ |
| K172115 | Navigated Instrument System | Orthofix, Inc. | 2018-03-08 | Special | PDF ↗ |
| K173338 | Navigated INFINITY Instruments | Medtronic Sofamor Danek USA, Inc. | 2018-01-18 | Traditional | PDF ↗ |
| K171556 | K2M Navigation Instruments | K2m | 2018-01-16 | Traditional | PDF ↗ |
| K172518 | Spineology Navigation Instruments | Spineology, Inc. | 2018-01-05 | Traditional | PDF ↗ |
| K172623 | NuVasive Navigation Instruments | Nu Vasive, Incorporated | 2017-12-21 | Traditional | PDF ↗ |
| K173372 | ExactechGPS Total Shoulder Application | Blue Ortho | 2017-11-24 | Special | PDF ↗ |
| K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017-11-22 | Traditional | PDF ↗ |
| K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | Intellijoint Surgical, Inc. | 2017-11-16 | Special | PDF ↗ |
| K172301 | Mako Partial Knee Application | Mako Surgical Corp. | 2017-11-02 | Special | PDF ↗ |
| K172268 | iFuse Implant System- iFuse Navigation | SI-BONE, Inc. | 2017-10-31 | Traditional | PDF ↗ |
| K171525 | Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | 2017-10-30 | Traditional | PDF ↗ |
| K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap | Stryker Corporation | 2017-10-18 | Traditional | PDF ↗ |
| K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017-09-21 | Traditional | PDF ↗ |
| K172522 | Mazor X | Mazor Robotics , Ltd. | 2017-09-15 | Special | PDF ↗ |
| K170937 | VIPER PRIME navigated inserter | Medos International SARL | 2017-09-14 | Traditional | PDF ↗ |
| K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017-09-01 | Traditional | PDF ↗ |
| K171321 | K2M Navigation Instruments | K2m | 2017-08-30 | Traditional | PDF ↗ |
| K171651 | EXCELSIUS GPS | Globus Medical, Inc. | 2017-08-16 | Traditional | PDF ↗ |
| K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017-07-11 | Special | PDF ↗ |
| K171267 | NavLock Trackers | Medtronic Navigation | 2017-07-03 | Traditional | PDF ↗ |
| K170891 | Mako Partial Knee Application | Mako Surgical Corp. | 2017-05-24 | Traditional | PDF ↗ |
| K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017-05-11 | Special | PDF ↗ |
| K170584 | Mako Partial Knee Application | Mako Surgical Corp. | 2017-05-11 | Special | PDF ↗ |
| K170977 | SURESHOT Distal Targeting System V4.0 Trauma Interface | Smith & Nephew, Inc. | 2017-05-03 | Special | PDF ↗ |
| K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017-05-02 | Traditional | PDF ↗ |
| K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017-05-01 | Traditional | PDF ↗ |
| K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 | Smith & Nephew, Inc. | 2017-04-28 | Traditional | PDF ↗ |
| K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017-04-18 | Special | PDF ↗ |
| K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017-04-14 | Traditional | PDF ↗ |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2017-04-05 | Traditional | PDF ↗ |
| K163221 | Mazor X | Mazor Robotics , Ltd. | 2017-04-04 | Traditional | PDF ↗ |
| K162921 | Navigated Instrument System | Orthofix, Inc. | 2017-03-13 | Traditional | PDF ↗ |
| K170430 | TSolution One Surgical System Model 210 | THINK Surgical, Inc. | 2017-03-06 | Special | PDF ↗ |
| K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | 2017-03-02 | Traditional | PDF ↗ |
| K163379 | KneeAlign 2 System | Orthalign, Inc. | 2017-03-02 | Traditional | PDF ↗ |
| K162937 | Stryker OrthoMap Versatile Hip System | Stryker Corporation | 2017-02-23 | Traditional | PDF ↗ |
| K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017-01-23 | Traditional | PDF ↗ |
| K162375 | Envision 3D: Image Guidance System | 7D Surgical, Inc. | 2016-12-29 | Traditional | PDF ↗ |
| K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016-10-12 | Traditional | PDF ↗ |
| K162195 | TSolution One Cup1 Surgical System | THINK Surgical, Inc. | 2016-09-14 | Special | PDF ↗ |
| K160385 | Precision Screw | Cryptych Pty, Ltd. | 2016-07-27 | Traditional | PDF ↗ |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments | Aesculap Implant Systems, LLC | 2016-07-08 | Traditional | PDF ↗ |
| K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016-07-07 | Traditional | PDF ↗ |
| K160713 | Stealth-Midas System | Medtronic Powered Surgical Solutions | 2016-05-26 | Traditional | PDF ↗ |
| K160537 | Navio | Blue Belt Technologies, Inc. | 2016-05-19 | Traditional | PDF ↗ |
| K153396 | Aesculap OrthoPilot Next Generation | Aesculap Implant Systems, LLC | 2016-05-16 | Traditional | PDF ↗ |
| K153603 | Alphatec Navigation Instruments | Alphatec Spine, Inc. | 2016-04-29 | Traditional | PDF ↗ |
| K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016-03-01 | Traditional | PDF ↗ |
| K153647 | TSolution One w/ACG+ Surgical System | THINK Surgical, Inc. | 2016-02-16 | Traditional | PDF ↗ |
| K153203 | Navigation Instruments | Globus Medical, Inc. | 2016-02-03 | Traditional | PDF ↗ |
| K151511 | ROSA Spine | Medtech S.A | 2016-01-04 | Traditional | PDF ↗ |
| K151364 | Intellijoint HIP(tm) System | Intellijoint Surgical, Inc. | 2015-12-28 | Traditional | PDF ↗ |
| K152041 | Renaissance X System | Mazor Robotics , Ltd. | 2015-11-17 | Special | PDF ↗ |
| K152574 | Navio | Blue Belt Technologies, Inc. | 2015-10-20 | Special | PDF ↗ |
| K142530 | Partial Knee Application (PKA) | Mako Surgical Corporation | 2015-09-16 | Traditional | PDF ↗ |
| K143597 | Navigated XIA 4.5 Polyaxial Screwdriver | Stryker Corporate | 2015-09-04 | Traditional | PDF ↗ |
| K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015-08-06 | Traditional | PDF ↗ |
| K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015-06-16 | Traditional | PDF ↗ |
| K143668 | Navio | Blue Belt Technologies, Inc. | 2015-03-20 | Traditional | PDF ↗ |
| K141694 | AESCULAP ORTHOPILOT NEXT GENERATION | Aesculap Implant Systems, LLC | 2015-02-24 | Special | PDF ↗ |
| K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015-02-12 | Traditional | PDF ↗ |
| K141989 | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM | Mako Surgical Corporation | 2014-11-13 | Special | PDF ↗ |
| 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 | 2014-10-31 | Traditional | PDF ↗ |
| K140927 | UNIVERSAL NAVIGATION INSTRUMENTS | Medos International SARL | 2014-10-24 | Traditional | PDF ↗ |
| K141601 | IASSIST KNEE SYSTEM | Zimmer Cas | 2014-09-11 | Special | PDF ↗ |
| K140167 | RENAISSANCE X SYSTEM | Mazor Robotics , Ltd. | 2014-09-10 | Traditional | PDF ↗ |
| K140689 | IKNEE DISTAL FEMORAL CUTTING GUIDE | Evergreen Orthopedic Research Lab | 2014-08-22 | Traditional | PDF ↗ |
| K133759 | INTELLIJOINT HIP | Intellijoint Surgical, Inc. | 2014-07-23 | Traditional | PDF ↗ |
| K140596 | NAVIO | Blue Belt Technologies, Inc. | 2014-07-02 | Traditional | PDF ↗ |
| K140331 | ORTHALIGN PLUS SYSTEM | Orthalign, Inc. | 2014-06-10 | Traditional | PDF ↗ |
| K140454 | NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS | Medtronic Sofamor Danek USA, Inc. | 2014-05-22 | Traditional | PDF ↗ |
| K130387 | ORTHOALIGN PLUS SYSTEM | Orthalign, Inc. | 2013-11-08 | Traditional | PDF ↗ |
| K131425 | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER | Medtronic Navigation, Inc. | 2013-08-14 | Traditional | PDF ↗ |
| K130887 | S4C NAVIGATION INSTRUMENTS | Aesculap Implant System, Inc. | 2013-08-13 | Traditional | PDF ↗ |
| K130748 | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 | Smith & Nephew, Inc. | 2013-08-04 | Traditional | PDF ↗ |
Product code OLO · Class II · Neurology. Data: openFDA.