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OLO

439 FDA 510(k) clearances · Product code

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RecordFirmDate
DeGen Navigated Instrumentation (K213918)Degen Medical2022-02-09
CoreLink Navigation Instruments (K214059)Corelink, LLC2022-01-19
iASSIST Knee System (K213033)Orthosoft D/B/A Zimmer Cas2022-01-14
360CAS (K213380)Kico Knee Innovation Company Pty Limited2022-01-11
Vital Navigation System (K213720)Zimvie (Zimmer Biomet Spine, Inc.)2022-01-07
ExactechGPS Total Shoulder Application, Equinoxe Planning Software (K213546)Blue Ortho2022-01-06
Integrity Implants Navigated Instruments (K212088)Integrity Implants, Inc.2021-12-23
REAL INTELLIGENCE CORI (CORI) (K212537)Blue Belt Technologies, Inc.2021-11-03
CoreLink Navigation Instruments (K212825)Corelink, LLC2021-10-13
Dark Star Navigation Instrument System (K212028)Republic Spine, LLC2021-09-27
Virage Navigation System (K212023)Zimmer Biomet Spine, Inc.2021-08-27
ExcelsiusHub (K211616)Globus Medical, Inc.2021-08-25
GX Navigation Instrument System (K202836)Life Spine, Inc.2021-08-19
VERTICALE Navigation Instruments (K212007)Silony Medical GmbH2021-08-12
NuVasive Pulse System (K210574)Nu Vasive, Incorporated2021-07-29
ARVIS Surgical Navigation System (K203115)Insight Medical Systems, Inc.2021-07-14
StealthStation Spinous Process Clamps (K211442)Medtronic Navigation2021-07-08
CD Horizon Spinal System (K211596)Medtronic2021-06-23
7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key (K210457)7D Surgical, Inc.2021-06-21
Navigated Anterolateral Disc Prep Instruments (K211441)Medtronic Sofamor Danek USA, Inc.2021-06-09
CUVIS-spine (K201569)Curexo, Inc.2021-05-19
ROSA Partial Knee System (K210121)Orthosoft D/B/A Zimmer Cas2021-04-19
OMNIVision system (K203751)Corin USA2021-04-12
DeGen Navigated Instrumentation (K203816)Degen Medical2021-04-02
TSolution One Total Knee Application (K210668)THINK Surgical, Inc.2021-04-01
Navigated Spine Instruments (K203205)Stryker Spine2021-03-23
7D Surgical System - Drill Guide (K210555)7D Surgical, Inc.2021-03-23
SPINEART Navigation Instrument System (K210472)Spineart2021-03-19
Automatic Registration (K203679)Brainlab AG2021-03-18
Erisma LP Navigated Instruments (K202956)Clariance, Sas2021-02-26
Practical Navigation Surgical Guidance System (PNSGS) (K202184)Practical Navigation, LLC2021-02-24
RESPONSE Navigation Instruments (K203573)OrthoPediatrics Corp.2021-02-04
VELYS™ Robotic-Assisted Solution (K202769)Depuy Ireland UC2021-01-14
ChoiceSpine Navigation System (K203561)Choice Spine, LLC2021-01-04
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System (K202320)Brainlab AG2020-12-23
ADAPT for Gamma3 (K202749)Stryker GmbH2020-12-18
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration (K200376)Navbit Pty, Ltd.2020-12-10
CD Horizon Spinal System Instruments (K203291)Medtronic Sofamor Danek USA, Inc.2020-12-08
NuVasive Navigation.S Instruments (K200719)Nu Vasive, Incorporated2020-12-02
TSolution One Total Knee Application (K203040)THINK Surgical, Inc.2020-11-13
iFuse Implant System - iFuse Navigation (K203110)SI-BONE, Inc.2020-11-09
Midas Rex Attachments and Dissecting Tools (K202552)Medtronic Powered Surgical Solutions (Mpss)2020-11-02
Mazor X (K203005)Mazor Robotics , Ltd.2020-10-27
Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set (K201661)Medos International SARL2020-09-16
Navigation Module of the Momentum System (K200845)Ulrich Medical USA2020-09-10
Perseus (K192653)Orthokey Italia S.R.L.2020-09-09
7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array (K201966)7D Surgical, Inc.2020-09-03
ExactechGPS System (K193618)Blue Ortho2020-09-02
K2M Navigation Instruments (K201006)K2m, Inc.2020-08-07
CarboClear Navigated Instruments (K201251)CarboFix Orthopedics , Ltd.2020-08-05
Navigation Enabled Intruments (K200791)Medos International SARL2020-07-31
Joimax Intracs System (K192663)Joimax GmbH2020-07-30
Mako Total Knee Application (K193515)Mako Surgical Corp.2020-07-14
ExcelsiusGPS Cranial 1.0 Module (K200047)Globus Medical, Inc.2020-07-10
OMNIBotics Knee System (K200888)Corin, Ltd.2020-06-27
Streamline Navigated Instruments (K200095)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2020-06-26
Harvey(R) Surgical Assistant (K200892)Orthalign, Inc.2020-06-18
NavLock Trackers (K201327)Medtronic Navigation2020-06-18
REAL INTELLIGENCE CORI (CORI) (K201022)Blue Belt Technologies, Inc.2020-06-12
TSolution® One Total Knee Application (K201255)THINK Surgical, Inc.2020-06-10
Naviswiss Hip Navigation System (K193094)Naviswiss AG2020-06-10
HIP7 (K193307)Brainlab AG2020-06-02
Stealthstation S8 Spine Software v1.3.0 (K201189)Medtronic Navigation, Inc.2020-05-29
Mazor X (K200935)Mazor Robotics , Ltd.2020-05-08
OrthAlign Plus System (K200642)Orthalign, Inc.2020-04-10
Real Intelligence Cori (K193120)Blue Belt Technologies, Inc.2020-02-14
Mako Total Hip Application (K193128)Mako Surgical Corp.2020-02-02
Black Diamond Navigation Instruments (K192495)Osseus Fusion Systems2020-01-17
Spinal Elements Navigated Instruments (K190881)Spinal Elements, Inc.2019-12-19
Corelink Navigation Instruments (K182731)Corelink, LLC2019-12-13
TSolution One Total Knee Application (K193135)THINK Surgical, Inc.2019-12-11
Vital Navigation System (K191722)Zimmer Biomet Spine, Inc.2019-12-02
Navigated Anterolateral Disc Prep Instruments (K192336)Medtronic Sofamor Danek USA, Inc.2019-11-22
Brainlab Compatible K2M Navigation Instruments (K192911)K2m, Inc.2019-11-14
7D Surgical System (K192140)7D Surgical, Inc.2019-11-05
iASSIST Knee System (K192080)Orthosoft Inc (D/B/A Zimmer Cas)2019-11-05
ROSA ONE Spine application (K192173)Medtech S.A2019-10-29
Zimmer Biomet Universal Navigation System (K192133)Zimmer Biomet Spine, Inc.2019-10-29
Zimmer Biomet Universal Navigation System (K190556)Zimmer Biomet Spine, Inc.2019-10-24
SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set (K191943)Medos International SARL2019-10-18
Spine Wave Navigated Instruments (K192526)Spine Wave, Inc.2019-10-10
TSolution One Total Knee Application (K191369)THINK Surgical, Inc.2019-10-08
Premia Spine XL Instruments (K191854)Premia Spine, Ltd.2019-10-08
Intellijoint® Navigation System (K191507)Intellijoint Surgical, Inc.2019-10-01
Precision Spine Navigation Instrumentation (K181606)Precision Spine, Inc.2019-09-27
Mako Total Hip Application, Mako Total Knee Application (K191998)Mako Surgical Corp.2019-09-24
INTAI Surgery Navigation System (K180523)Intai Technology Corporation2019-09-20
Spine & Trauma Navigation (K183605)Brainlab AG2019-08-29
Navigated T2 STRATOSPHERE Inserters and Navigated Templates (K191039)Medtronic Sofamor Danek USA, Inc.2019-08-26
Navigated Pedicle Access Kit (K191012)Izi Medical Products, LLC2019-08-07
ExcelsiusGPS Spine 1.1 Interbody Module (K191100)Globus Medical, Inc.2019-07-24
NAVIO (K191223)Blue Belt Technologies, Inc.2019-06-28
GALILEO Spine Alignment Monitoring System (K182524)MiRus, LLC2019-06-17
Spine & Trauma Navigation (K191285)Brainlab AG2019-06-11
SPINEART Navigation Instrument System (K183630)Spineart SA2019-06-10
Stealth-Midas MR8 System (K183644)Medtronic Powered Surgical Solutions2019-05-22
Navigation Enabled Instruments (K183381)Stryker2019-05-17
ExcelsiusGPS (K190653)Globus Medical, Inc.2019-04-09
ROSA ONE Spine application (K182848)Medtech S.A2019-03-22
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker (K183196)Stryker Corporation2019-02-14
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