ClearanceBrief
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
Aug 14, 2013K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
Medtronic Navigation, Inc.
OLO
Aug 13, 2013K130887S4C NAVIGATION INSTRUMENTS
Aesculap Implant System, Inc.
OLO
Aug 4, 2013K130748SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
Smith & Nephew, Inc.
OLO
Jul 19, 2013K131130NAVIGATION PIN
Evergreen Orthopedic Research Lab
OLO
Mar 22, 2013K124004NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
Medtronic Navigation, Inc.
OLO
Jan 11, 2013K121765SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
Stanmore Implants Worldwide , Ltd.
OLO
Dec 7, 2012K122742NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
Nuvasive, Inc.
OLO
Nov 30, 2012K122326SMARTTOOLS KNEE SYSTEM
Zimmer, CA
OLO
Nov 30, 2012K121936NAVIOPFS
Blue Belt Technologies, Inc.
OLO
Nov 15, 2012K122011NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
Brainlab AG, DE
OLO
Sep 20, 2012K120867VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
Medos International SARL
OLO
Jun 6, 2012K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
Mako Surgical Corporation
OLO
Mar 1, 2012K112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
Mako Surgical Corporation
OLO
Dec 5, 2011K111811BENDINI(TM) SPINAL ROD BENDING SYSTEM
Nuvasive, Inc.
OLO
Nov 14, 2011K111843ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
Smith & Nephew Inc., Endoscopy Div.
OLO
Oct 18, 2011K110021DASH HIP
Brainlab AG, DE
OLO
Sep 29, 2011K111443X12 STERILE REFLECTIVE MARKER SPHERE
Pinsco Inc. Dba B & L Engineering
OLO
Aug 5, 2011K110204BRAINLAB TRAUMA
Brainlab AG, DE
OLO
May 17, 2011K102251DASH KNEE
Brainlab AG, DE
OLO
Apr 14, 2011K110240SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
Smith & Nephew, Inc.
OLO
Apr 4, 2011K103829KNEEALIGN SYSTEM
Orthalign, Inc.
OLO
Apr 4, 2011K102990BRAINLAB KNEE
Brainlab AG, DE
OLO
Mar 24, 2011K110054NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
Zimmer Cas, CA
OLO
Mar 7, 2011K103400FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
Stryker Corporation, DE
OLO
Nov 4, 2010K102967SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
Smith & Newphew, Inc.
OLO
Oct 21, 2010K100742EXACTECH GPS
Blue Ortho, FR
OLO
Aug 4, 2010K093206ORTHOMAP 3D 1.1 MODULE
Stryker Corp., DE
OLO
Jun 11, 2010K093118BRAINLAB KNEE ARTHROSCOPY
Brainlab AG, DE
OLO
Apr 5, 2010K100599CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
Orthosoft, Inc., CA
OLO
Mar 22, 2010K093998KNEEALIGN SYSTEM WITH REFERENCE SENSOR
Orthalign, Inc.
OLO
Feb 24, 2010K093425MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
Mako Surgical Corp.
OLO
Feb 23, 2010K100107SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
Smith & Nephew, Inc.
OLO
Jan 21, 2010K090953TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
Praxim Medivision, SA, FR
OLO
Sep 28, 2009K091998ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
Mako Surgical Corp.
OLO
Sep 25, 2009K091411KNEEALIGN SYSTEM
Orthalign, Inc.
OLO
Sep 11, 2009K092497SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
Smith & Nephew, Inc.
OLO
Jun 23, 2009K090375ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
Aesculap Implant System, Inc.
OLO
Jun 19, 2009K083644MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP
Mako Surgical Corp.
OLO
May 27, 2009K090420SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
Smith & Nephew, Inc.
OLO
Apr 8, 2009K083483BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
Brainlab AG, DE
OLO
Apr 1, 2009K083310SPINE & TRAUMA ICT
Brainlab AG, DE
OLO
Mar 11, 2009K090313PIGALILEO TKR BASE V2.3 AND CAS V4.1
Smith & Nephew, Inc.
OLO
Feb 19, 2009K083009ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
Stryker Leibinger GmbH & Co KG, DE
OLO
Jan 15, 2009K083872IMNS MEDACTA NAVIGATION SYSTEM
Medacta International S.A.
OLO

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