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Panels › Neurology › Product code OLO · Class 2

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)
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Top companies in OLO

Company510(k)sRecalls
Mako Surgical Corp.2325
Brainlab AG216
Medtronic Navigation1214
THINK Surgical, Inc.204
Blue Belt Technologies, Inc.183
Medtronic Sofamor Danek USA, Inc.161
Globus Medical, Inc.132
Mazor Robotics , Ltd.104
Orthalign, Inc.122
Orthosoft D/B/A Zimmer Cas130
Decided510(k)Device and applicantCode
Apr 15, 2022K220459Mako Total Knee Application
Mako Surgical Corp.
OLO
Apr 13, 2022K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software
Brainlab AG, DE
OLO
Mar 31, 2022K220291NEXXT SPINE NAVIGATION System
Nexxt Spine, LLC
OLO
Mar 29, 2022K220255REAL INTELLIGENCE CORI
Blue Belt Technologies, Inc.
OLO
Feb 9, 2022K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surfac
Medtronic Sofamor Danek USA, Inc.
OLO
Feb 9, 2022K213918DeGen Navigated Instrumentation
Degen Medical
OLO
Jan 19, 2022K214059CoreLink Navigation Instruments
Corelink, LLC
OLO
Jan 14, 2022K213033iASSIST Knee System
Orthosoft D/B/A Zimmer Cas, CA
OLO
Jan 11, 2022K213380360CAS
Kico Knee Innovation Company Pty Limited, AU
OLO
Jan 7, 2022K213720Vital Navigation System
Zimvie (Zimmer Biomet Spine, Inc.)
OLO
Jan 6, 2022K213546ExactechGPS Total Shoulder Application, Equinoxe Planning Software
Blue Ortho, FR
OLO
Dec 23, 2021K212088Integrity Implants Navigated Instruments
Integrity Implants, Inc.
OLO
Nov 3, 2021K212537REAL INTELLIGENCE CORI (CORI)
Blue Belt Technologies, Inc.
OLO
Oct 13, 2021K212825CoreLink Navigation Instruments
Corelink, LLC
OLO
Sep 27, 2021K212028Dark Star Navigation Instrument System
Republic Spine, LLC
OLO
Aug 27, 2021K212023Virage Navigation System
Zimmer Biomet Spine, Inc.
OLO
Aug 25, 2021K211616ExcelsiusHub
Globus Medical, Inc.
OLO
Aug 19, 2021K202836GX Navigation Instrument System
Life Spine, Inc.
OLO
Aug 12, 2021K212007VERTICALE Navigation Instruments
Silony Medical GmbH, DE
OLO
Jul 29, 2021K210574NuVasive Pulse System
Nu Vasive, Incorporated
OLO
Jul 14, 2021K203115ARVIS Surgical Navigation System
Insight Medical Systems, Inc.
OLO
Jul 8, 2021K211442StealthStation Spinous Process Clamps
Medtronic Navigation
OLO
Jun 23, 2021K211596CD Horizon Spinal System
Medtronic
OLO
Jun 21, 2021K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuc
7D Surgical, Inc., CA
OLO
Jun 9, 2021K211441Navigated Anterolateral Disc Prep Instruments
Medtronic Sofamor Danek USA, Inc.
OLO
May 19, 2021K201569CUVIS-spine
Curexo, Inc., KR
OLO
Apr 19, 2021K210121ROSA Partial Knee System
Orthosoft D/B/A Zimmer Cas, CA
OLO
Apr 12, 2021K203751OMNIVision system
Corin USA
OLO
Apr 2, 2021K203816DeGen Navigated Instrumentation
Degen Medical
OLO
Apr 1, 2021K210668TSolution One Total Knee Application
THINK Surgical, Inc.
OLO
Mar 23, 2021K2105557D Surgical System - Drill Guide
7D Surgical, Inc., CA
OLO
Mar 23, 2021K203205Navigated Spine Instruments
Stryker Spine
OLO
Mar 19, 2021K210472SPINEART Navigation Instrument System
Spineart, CH
OLO
Mar 18, 2021K203679Automatic Registration
Brainlab AG, DE
OLO
Feb 26, 2021K202956Erisma LP Navigated Instruments
Clariance, Sas, FR
OLO
Feb 24, 2021K202184Practical Navigation Surgical Guidance System (PNSGS)
Practical Navigation, LLC
OLO
Feb 4, 2021K203573RESPONSE Navigation Instruments
OrthoPediatrics Corp.
OLO
Jan 14, 2021K202769VELYS™ Robotic-Assisted Solution
Depuy Ireland UC, IE
OLO
Jan 4, 2021K203561ChoiceSpine Navigation System
Choice Spine, LLC
OLO
Dec 23, 2020K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIR
Brainlab AG, DE
OLO
Dec 18, 2020K202749ADAPT for Gamma3
Stryker GmbH
OLO
Dec 10, 2020K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration
Navbit Pty, Ltd., AU
OLO
Dec 8, 2020K203291CD Horizon Spinal System Instruments
Medtronic Sofamor Danek USA, Inc.
OLO
Dec 2, 2020K200719NuVasive Navigation.S Instruments
Nu Vasive, Incorporated
OLO
Nov 13, 2020K203040TSolution One Total Knee Application
THINK Surgical, Inc.
OLO
Nov 9, 2020K203110iFuse Implant System - iFuse Navigation
SI-BONE, Inc.
OLO
Nov 2, 2020K202552Midas Rex Attachments and Dissecting Tools
Medtronic Powered Surgical Solutions (Mpss)
OLO
Oct 27, 2020K203005Mazor X
Mazor Robotics , Ltd., IL
OLO
Sep 16, 2020K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set
Medos International SARL, CH
OLO
Sep 10, 2020K200845Navigation Module of the Momentum System
Ulrich Medical USA
OLO

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