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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220255 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | 2022-03-29 | Traditional | PDF ↗ |
| K214011 | Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers | Medtronic Sofamor Danek USA, Inc. | 2022-02-09 | Special | PDF ↗ |
| K213918 | DeGen Navigated Instrumentation | Degen Medical | 2022-02-09 | Traditional | PDF ↗ |
| K214059 | CoreLink Navigation Instruments | Corelink, LLC | 2022-01-19 | Special | PDF ↗ |
| K213033 | iASSIST Knee System | Orthosoft D/B/A Zimmer Cas | 2022-01-14 | Traditional | PDF ↗ |
| K213380 | 360CAS | Kico Knee Innovation Company Pty Limited | 2022-01-11 | Traditional | PDF ↗ |
| K213720 | Vital Navigation System | Zimvie (Zimmer Biomet Spine, Inc.) | 2022-01-07 | Special | PDF ↗ |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022-01-06 | Traditional | PDF ↗ |
| K212088 | Integrity Implants Navigated Instruments | Integrity Implants, Inc. | 2021-12-23 | Traditional | PDF ↗ |
| K212537 | REAL INTELLIGENCE CORI (CORI) | Blue Belt Technologies, Inc. | 2021-11-03 | Traditional | PDF ↗ |
| K212825 | CoreLink Navigation Instruments | Corelink, LLC | 2021-10-13 | Traditional | PDF ↗ |
| K212028 | Dark Star Navigation Instrument System | Republic Spine, LLC | 2021-09-27 | Traditional | PDF ↗ |
| K212023 | Virage Navigation System | Zimmer Biomet Spine, Inc. | 2021-08-27 | Traditional | PDF ↗ |
| K211616 | ExcelsiusHub | Globus Medical, Inc. | 2021-08-25 | Traditional | PDF ↗ |
| K202836 | GX Navigation Instrument System | Life Spine, Inc. | 2021-08-19 | Traditional | PDF ↗ |
| K212007 | VERTICALE Navigation Instruments | Silony Medical GmbH | 2021-08-12 | Traditional | PDF ↗ |
| K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | 2021-07-29 | Traditional | PDF ↗ |
| K203115 | ARVIS Surgical Navigation System | Insight Medical Systems, Inc. | 2021-07-14 | Traditional | PDF ↗ |
| K211442 | StealthStation Spinous Process Clamps | Medtronic Navigation | 2021-07-08 | Traditional | PDF ↗ |
| K211596 | CD Horizon Spinal System | Medtronic | 2021-06-23 | Special | PDF ↗ |
| K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key | 7D Surgical, Inc. | 2021-06-21 | Traditional | PDF ↗ |
| K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2021-06-09 | Special | PDF ↗ |
| K201569 | CUVIS-spine | Curexo, Inc. | 2021-05-19 | Traditional | PDF ↗ |
| K210121 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | 2021-04-19 | Traditional | PDF ↗ |
| K203751 | OMNIVision system | Corin USA | 2021-04-12 | Traditional | PDF ↗ |
| K203816 | DeGen Navigated Instrumentation | Degen Medical | 2021-04-02 | Traditional | PDF ↗ |
| K210668 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2021-04-01 | Special | PDF ↗ |
| K203205 | Navigated Spine Instruments | Stryker Spine | 2021-03-23 | Traditional | PDF ↗ |
| K210555 | 7D Surgical System - Drill Guide | 7D Surgical, Inc. | 2021-03-23 | Special | PDF ↗ |
| K210472 | SPINEART Navigation Instrument System | Spineart | 2021-03-19 | Special | PDF ↗ |
| K203679 | Automatic Registration | Brainlab AG | 2021-03-18 | Special | PDF ↗ |
| K202956 | Erisma LP Navigated Instruments | Clariance, Sas | 2021-02-26 | Traditional | PDF ↗ |
| K202184 | Practical Navigation Surgical Guidance System (PNSGS) | Practical Navigation, LLC | 2021-02-24 | Traditional | PDF ↗ |
| K203573 | RESPONSE Navigation Instruments | OrthoPediatrics Corp. | 2021-02-04 | Traditional | PDF ↗ |
| K202769 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | 2021-01-14 | Traditional | PDF ↗ |
| K203561 | ChoiceSpine Navigation System | Choice Spine, LLC | 2021-01-04 | Special | PDF ↗ |
| K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab AG | 2020-12-23 | Traditional | PDF ↗ |
| K202749 | ADAPT for Gamma3 | Stryker GmbH | 2020-12-18 | Traditional | PDF ↗ |
| K200376 | Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration | Navbit Pty, Ltd. | 2020-12-10 | Traditional | PDF ↗ |
| K203291 | CD Horizon Spinal System Instruments | Medtronic Sofamor Danek USA, Inc. | 2020-12-08 | Special | PDF ↗ |
| K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | 2020-12-02 | Traditional | PDF ↗ |
| K203040 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2020-11-13 | Special | PDF ↗ |
| K203110 | iFuse Implant System - iFuse Navigation | SI-BONE, Inc. | 2020-11-09 | Special | PDF ↗ |
| K202552 | Midas Rex Attachments and Dissecting Tools | Medtronic Powered Surgical Solutions (Mpss) | 2020-11-02 | Traditional | PDF ↗ |
| K203005 | Mazor X | Mazor Robotics , Ltd. | 2020-10-27 | Special | PDF ↗ |
| K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2020-09-16 | Traditional | PDF ↗ |
| K200845 | Navigation Module of the Momentum System | Ulrich Medical USA | 2020-09-10 | Traditional | PDF ↗ |
| K192653 | Perseus | Orthokey Italia S.R.L. | 2020-09-09 | Traditional | PDF ↗ |
| K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array | 7D Surgical, Inc. | 2020-09-03 | Special | PDF ↗ |
| K193618 | ExactechGPS System | Blue Ortho | 2020-09-02 | Traditional | PDF ↗ |
| K201006 | K2M Navigation Instruments | K2m, Inc. | 2020-08-07 | Special | PDF ↗ |
| K201251 | CarboClear Navigated Instruments | CarboFix Orthopedics , Ltd. | 2020-08-05 | Traditional | PDF ↗ |
| K200791 | Navigation Enabled Intruments | Medos International SARL | 2020-07-31 | Traditional | PDF ↗ |
| K192663 | Joimax Intracs System | Joimax GmbH | 2020-07-30 | Traditional | PDF ↗ |
| K193515 | Mako Total Knee Application | Mako Surgical Corp. | 2020-07-14 | Traditional | PDF ↗ |
| K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | 2020-07-10 | Traditional | PDF ↗ |
| K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020-06-27 | Traditional | PDF ↗ |
| K200095 | Streamline Navigated Instruments | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2020-06-26 | Traditional | PDF ↗ |
| K200892 | Harvey(R) Surgical Assistant | Orthalign, Inc. | 2020-06-18 | Special | PDF ↗ |
| K201327 | NavLock Trackers | Medtronic Navigation | 2020-06-18 | Special | PDF ↗ |
| K201022 | REAL INTELLIGENCE CORI (CORI) | Blue Belt Technologies, Inc. | 2020-06-12 | Special | PDF ↗ |
| K193094 | Naviswiss Hip Navigation System | Naviswiss AG | 2020-06-10 | Traditional | PDF ↗ |
| K201255 | TSolution® One Total Knee Application | THINK Surgical, Inc. | 2020-06-10 | Special | PDF ↗ |
| K193307 | HIP7 | Brainlab AG | 2020-06-02 | Traditional | PDF ↗ |
| K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. | 2020-05-29 | Special | PDF ↗ |
| K200935 | Mazor X | Mazor Robotics , Ltd. | 2020-05-08 | Special | PDF ↗ |
| K200642 | OrthAlign Plus System | Orthalign, Inc. | 2020-04-10 | Special | PDF ↗ |
| K193120 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2020-02-14 | Traditional | PDF ↗ |
| K193128 | Mako Total Hip Application | Mako Surgical Corp. | 2020-02-02 | Traditional | PDF ↗ |
| K192495 | Black Diamond Navigation Instruments | Osseus Fusion Systems | 2020-01-17 | Traditional | PDF ↗ |
| K190881 | Spinal Elements Navigated Instruments | Spinal Elements, Inc. | 2019-12-19 | Traditional | PDF ↗ |
| K182731 | Corelink Navigation Instruments | Corelink, LLC | 2019-12-13 | Traditional | PDF ↗ |
| K193135 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019-12-11 | Special | PDF ↗ |
| K191722 | Vital Navigation System | Zimmer Biomet Spine, Inc. | 2019-12-02 | Traditional | PDF ↗ |
| K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019-11-22 | Traditional | PDF ↗ |
| K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019-11-14 | Special | PDF ↗ |
| K192140 | 7D Surgical System | 7D Surgical, Inc. | 2019-11-05 | Traditional | PDF ↗ |
| K192080 | iASSIST Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-11-05 | Traditional | PDF ↗ |
| K192173 | ROSA ONE Spine application | Medtech S.A | 2019-10-29 | Traditional | PDF ↗ |
| K192133 | Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | 2019-10-29 | Traditional | PDF ↗ |
| K190556 | Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | 2019-10-24 | Traditional | PDF ↗ |
| K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set | Medos International SARL | 2019-10-18 | Traditional | PDF ↗ |
| K192526 | Spine Wave Navigated Instruments | Spine Wave, Inc. | 2019-10-10 | Special | PDF ↗ |
| K191854 | Premia Spine XL Instruments | Premia Spine, Ltd. | 2019-10-08 | Traditional | PDF ↗ |
| K191369 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019-10-08 | Traditional | PDF ↗ |
| K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | 2019-10-01 | Traditional | PDF ↗ |
| K181606 | Precision Spine Navigation Instrumentation | Precision Spine, Inc. | 2019-09-27 | Traditional | PDF ↗ |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019-09-24 | Traditional | PDF ↗ |
| K180523 | INTAI Surgery Navigation System | Intai Technology Corporation | 2019-09-20 | Traditional | PDF ↗ |
| K183605 | Spine & Trauma Navigation | Brainlab AG | 2019-08-29 | Traditional | PDF ↗ |
| K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019-08-26 | Traditional | PDF ↗ |
| K191012 | Navigated Pedicle Access Kit | Izi Medical Products, LLC | 2019-08-07 | Traditional | PDF ↗ |
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019-07-24 | Traditional | PDF ↗ |
| K191223 | NAVIO | Blue Belt Technologies, Inc. | 2019-06-28 | Special | PDF ↗ |
| K182524 | GALILEO Spine Alignment Monitoring System | MiRus, LLC | 2019-06-17 | Traditional | PDF ↗ |
| K191285 | Spine & Trauma Navigation | Brainlab AG | 2019-06-11 | Special | PDF ↗ |
| K183630 | SPINEART Navigation Instrument System | Spineart SA | 2019-06-10 | Traditional | PDF ↗ |
| K183644 | Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | 2019-05-22 | Traditional | PDF ↗ |
| K183381 | Navigation Enabled Instruments | Stryker | 2019-05-17 | Traditional | PDF ↗ |
| K190653 | ExcelsiusGPS | Globus Medical, Inc. | 2019-04-09 | Special | PDF ↗ |
Product code OLO · Class II · Neurology. Data: openFDA.