Orthopedic Stereotaxic Instrument
FDA product code OLO · 420 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.4560
- Review panel
- OR
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2009-01-15 – 2026-08-20
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
OLO
2019-02-14
OLO
2019-01-24
ROSA Knee System
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OLO
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Choice Spine Navigation System
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2019-01-04
BridalVeil Navigated Instruments
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Brainlab Compatible K2M Navigation Instruments
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OLO
2018-11-02
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
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OLO
2018-11-02
NavLock Trackers, Robotic Reference Frame
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OLO
2018-11-02
Mazor X System (Mazor X Stealth Edition)
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OLO
2018-10-24
Spine Wave Navigated Instruments
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OLO
2018-10-12
ADAPT for Gamma3, Gamma3
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OLO
2018-09-21
Spineology Navigation Instruments
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OLO
2018-09-19
Ortoma Treatment Solution - OTS
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OLO
2018-07-11
Ziehm RFD 3D Tracker
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OLO
2018-06-29
NuVasive Pulse System
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OLO
2018-06-25
Navigation Instruments
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OLO
2018-05-17
Navigated INFINITY Instruments
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OLO
2018-05-11
SeaSpine Navigation System
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OLO
2018-05-02
Spineology Navigation Instruments
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OLO
2018-05-02
7D Surgical System
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OLO
2018-05-02
ADAPT for Gamma3
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OLO
2018-04-30
Mazor X
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OLO
2018-04-27
OLYMPIC Navigated Instruments
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OLO
2018-04-24
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
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OLO
2018-04-06
NAVIO™ Surgical System (NAVIO system)
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OLO
2018-03-08
Navigated Instrument System
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OLO
2018-01-18
Navigated INFINITY™ Instruments
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OLO
2018-01-16
K2M Navigation Instruments
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OLO
2018-01-05
Spineology Navigation Instruments
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OLO
2017-12-21
NuVasive Navigation Instruments
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OLO
2017-11-24
ExactechGPS Total Shoulder Application
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OLO
2017-11-22
OrthAlign Plus System
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OLO
2017-11-16
Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray
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OLO
2017-11-02
Mako Partial Knee Application
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OLO
2017-10-31
iFuse Implant System- iFuse Navigation
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OLO
2017-10-30
Intellijoint HIP Generation 2B System
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OLO
2017-10-18
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
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OLO
2017-09-21
Mako Total Knee Application
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OLO
2017-09-15
Mazor X
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OLO
2017-09-14
VIPER PRIME navigated inserter
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OLO
2017-09-01
OMNIBotics Knee System
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OLO
2017-08-30
K2M Navigation Instruments
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OLO
2017-08-16
EXCELSIUS GPS
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OLO
2017-07-11
OrthAlign Plus System
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OLO
2017-07-03
NavLock Trackers
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OLO
2017-05-24
Mako Partial Knee Application
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OLO
2017-05-11
Mako Partial Knee Application
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OLO
2017-05-11
Mako Total Knee Application
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OLO
2017-05-03
SURESHOT Distal Targeting System V4.0 Trauma Interface
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OLO
2017-05-02
NAVIO
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OLO
2017-05-01
StealthStation S8 Spine Software v1.0.0
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OLO
2017-04-28
Smith & Nephew SURESHOT Distal Targeting System V4.0
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OLO
2017-04-18
Mako Total Hip Application
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OLO
2017-04-14
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
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OLO
2017-04-05
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
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OLO
2017-04-04
Mazor X
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OLO
2017-03-13
Navigated Instrument System
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OLO
2017-03-06
TSolution One Surgical System Model 210
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OLO
2017-03-02
KneeAlign 2 System
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OLO
2017-03-02
Intellijoint HIP Generation 2A System
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OLO
2017-02-23
Stryker OrthoMap Versatile Hip System
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OLO
2017-01-23
OrthAlign Plus System
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OLO
2016-12-29
Envision 3D: Image Guidance System
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OLO
2016-10-12
Stryker OrthoMap Precision Knee system
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OLO
2016-09-14
TSolution One Cup1 Surgical System
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OLO
2016-07-27
Precision Screw
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OLO
2016-07-08
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
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OLO
2016-07-07
Styrker OrthoMap Express Knee System
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OLO
2016-05-26
Stealth-Midas System
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OLO
2016-05-19
Navio
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OLO
2016-05-16
Aesculap OrthoPilot Next Generation
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OLO
2016-04-29
Alphatec Navigation Instruments
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OLO
2016-03-01
OrthAlign Plus System
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OLO
2016-02-16
TSolution One w/ACG+ Surgical System
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OLO
2016-02-03
Navigation Instruments
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OLO
2016-01-04
ROSA Spine
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OLO
2013-11-08
ORTHOALIGN PLUS SYSTEM
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OLO
2013-08-14
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
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OLO
2013-08-13
S4C NAVIGATION INSTRUMENTS
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OLO
2013-08-04
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
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OLO
2013-07-19
NAVIGATION PIN
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OLO
2013-03-22
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
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OLO
2013-01-11
SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
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OLO
2012-12-07
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
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OLO
2012-11-30
SMARTTOOLS KNEE SYSTEM
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OLO
2012-11-30
NAVIOPFS
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OLO
2012-11-15
NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
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OLO
2012-09-20
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
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OLO
2012-06-06
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
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OLO
2012-03-01
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
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OLO
2011-12-05
BENDINI(TM) SPINAL ROD BENDING SYSTEM
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OLO
2011-11-14
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
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OLO
2011-10-18
DASH HIP
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OLO
2011-09-29
X12 STERILE REFLECTIVE MARKER SPHERE
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OLO
2011-08-05
BRAINLAB TRAUMA
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OLO
2011-05-17
DASH KNEE
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OLO
2011-04-14
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
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OLO
2011-04-04
KNEEALIGN SYSTEM
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OLO
2011-04-04
BRAINLAB KNEE
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OLO
2011-03-24
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
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OLO
2011-03-07
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
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