OLO · Class II · 21 CFR 882.4560

FDA Product Code OLO: Orthopedic Stereotaxic Instrument

FDA product code OLO covers orthopedic stereotaxic instruments.

These are computer-assisted navigation systems that provide real-time spatial guidance during orthopedic joint and spine surgery. They help surgeons achieve precise implant placement and trajectory planning.

OLO devices are Class II medical devices, regulated under 21 CFR 882.4560 and reviewed by the FDA Orthopedic panel. Neurological stereotaxic instruments are classified separately under product code HAW.

Leading manufacturers include Brainlab AG, THINK Surgical, Inc. and Medtronic Sofamor Danek USA, Inc..

439
Total
439
Cleared
121d
Avg days
2009
Since
439 devices
313–336 of 439
Cleared Apr 24, 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Apr 06, 2018
NAVIO™ Surgical System (NAVIO system)
K180271
Blue Belt Technologies, Inc.
Orthopedic · 65d
Cleared Mar 08, 2018
Navigated Instrument System
K172115
Orthofix, Inc.
Orthopedic · 238d
Cleared Jan 18, 2018
Navigated INFINITY™ Instruments
K173338
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Jan 16, 2018
K2M Navigation Instruments
K171556
K2m
Orthopedic · 231d
Cleared Jan 05, 2018
Spineology Navigation Instruments
K172518
Spineology, Inc.
Orthopedic · 137d
Cleared Dec 21, 2017
NuVasive Navigation Instruments
K172623
Nu Vasive, Incorporated
Orthopedic · 111d
Cleared Oct 18, 2017
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
K172034
Stryker Corporation
Orthopedic · 105d
Cleared Sep 14, 2017
VIPER PRIME navigated inserter
K170937
Medos International SARL
Orthopedic · 168d
Cleared Aug 16, 2017
EXCELSIUS GPS
K171651
Globus Medical, Inc.
Orthopedic · 72d
Cleared May 03, 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Apr 28, 2017
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 115d
Cleared Mar 13, 2017
Navigated Instrument System
K162921
Orthofix, Inc.
Orthopedic · 146d
Cleared Feb 23, 2017
Stryker OrthoMap Versatile Hip System
K162937
Stryker Corporation
Orthopedic · 126d
Cleared Apr 29, 2016
Alphatec Navigation Instruments
K153603
Alphatec Spine, Inc.
Orthopedic · 134d
Cleared Feb 03, 2016
Navigation Instruments
K153203
Globus Medical, Inc.
Orthopedic · 91d
Cleared Jun 16, 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 134d
Cleared Feb 12, 2015
Navigated Vertex Select Instruments
K143628
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
Cleared Oct 24, 2014
UNIVERSAL NAVIGATION INSTRUMENTS
K140927
Medos International SARL
Orthopedic · 196d
Cleared May 22, 2014
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Aug 14, 2013
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
K131425
Medtronic Navigation, Inc.
Orthopedic · 89d
Cleared Aug 04, 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748
Smith & Nephew, Inc.
Orthopedic · 138d
Cleared Mar 22, 2013
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
K124004
Medtronic Navigation, Inc.
Orthopedic · 86d